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AUTHENTICATED ,
US. GOVERNMENT
INFORMATION ^

FEDERAL OVERSIGHT OF HIGH-CONTAINMENT
BIOLABORATORIES

HEARING

BEFORE THE

SUBCOMMITTEE ON OA^RSIGHT AND
im^STIGATIONS

OF THE

COMMITTEE ON ENERGY AND
COMMERCE

HOUSE OF REPRESENTATDH]S

ONE HUNDRED ELEVENTH CONGRESS

FIRST SESSION

SEPTEMBER 22, 2009

Serial No. 111-66

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COMMITTEE ON ENERGY AND COMMERCE

HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan
Chairman Emeritus
EDWARD J. MARKEY, Massachusetts

RICK BOUCHER, Virginia
FRANK PALLONE, jR., New Jersey
BART GORDON, Tennessee
BOBBY L. RUSH, Illinois
ANNA G. ESHOO, California
BART STUPAK, Michigan
ELIOT L. ENGEL, New York
GENE GREEN, Texas
DIANA DeGETTE, Colorado
Vice Chairman
LOIS CAPPS, California
MICHAEL F. DOYLE, Pennsylvania
JANE HARMAN, California
TOM ALLEN, Maine
JANICE D. SCHAKOWSKY, Illinois
CHARLES A. GONZALEZ, Texas
JAY INSLEE, Washington
TAMMY BALDWIN, Wisconsin
MIKE ROSS, Arkansas
ANTHONY D. WEINER, New York
JIM MATHESON, Utah
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE BRALEY, Iowa
PETER WELCH, Vermont

JOE BARTON, Texas
Ranking Member
RALPH M. HALL, Texas
FRED UPTON, Michigan
CLIFF STEARNS, Florida
NATHAN DEAL, Georgia
ED WHITFIELD, Kentucky
JOHN SHIMKUS, Illinois
JOHN B. SHADEGG, Arizona
ROY BLUNT, Missouri
STEVE BUYER, Indiana
GEORGE RADANOVICH, California
JOSEPH R. PITTS, Pennsylvania
MARY BONO MACK, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska
MIKE ROGERS, Michigan
SUE WILKINS MYRICK, North Carolina
JOHN SULLIVAN, Oklahoma
TIM MURPHY, Pennsylvania
MICHAEL C. BURGESS, Texas
MARSHA BLACKBURN, Tennessee
PHIL GINGREY, Georgia
STEVE SCALISE, Louisiana

(II)

Subcommittee on Oversight and Investigations

BAET STUPAK, Michigan, Chairman

BRUCE L. BRALEY, Iowa
Vice Chairman

EDWARD J. MARKEY, Massachusetts

DIANA DeGETTE, Colorado

MICHAEL F. DOYLE, Pennsylvania

JANICE D. SCHAKOWSKY, Illinois

MIKE ROSS, Arkansas

DONNA M. CHRISTENSEN, Virgin Islands

PETER WELCH, Vermont

GENE GREEN, Texas

BETTY SUTTON, Ohio

JOHN D. DINGELL, Michigan (ex officio)

GREG WALDEN, Oregon
Ranking Member
ED WHITFIELD, Kentucky
MIKE FERGUSON, New Jersey
TIM MURPHY, Pennsylvania
MICHAEL C. BURGESS, Texas

(III)

CONTENTS

Page

Hon. Bart Stupak, a Representative in Congress from the State of Michigan,

opening statement 1

Hon. Greg Walden, a Representative in Congress from the State of Oregon,

opening statement 3

Prepared statement 6

Hon. Donna M. Christensen, a Representative in Congress from the Virgin

Islands, opening statement 10

Hon. Gene Green, a Representative in Congress from the State of Texas,

opening statement 10

Hon. John D. Dingell, a Representative in Congress from the State of Michi-
gan, prepared statement 12

Hon. Edward J. Markey, a Representative in Congress from the Common-
wealth of Massachusetts, prepared statement 13

Hon. Joe Barton, a Representative in Congress from the State of Texas,

prepared statement 15

Hon. Michael C. Burgess, a Representative in Congress from the State of
Texas, prepared statement 18

Witnesses

Nancy Kingsbury, Ph.D., Managing Director, accompanied by Sushil Sharma,
Assistant Director, Applied Research and Methods, U.S. Government Ac-
countability Office 21

Prepared statement 25

Ronald M. Atlas, Ph.D., Co-Chair, Committee on Biodefense, American Soci-
ety for Microbiology 34

Prepared statement 37

(V)

FEDERAL OVERSIGHT OF HIGH-
CONTAINMENT BIOLABORATORIES

TUESDAY, SEPTEMBER 22, 2009

House of Representatives,

Subcommittee on Oversight and Investigations,

Committee on Energy and Commerce,

Washington, DC.

The subcommittee met, pursuant to call, at 11:00 a.m., in Room
2123, Rayburn House Office Building, Hon. Bart Stupak [chairman
of the subcommittee] presiding.

Present: Representatives Stupak, Christensen, Green, Walden,
Burgess and Gingrey.

Staff Present: Mike Gordon, Chief Investigative Counsel; Dave
Leviss, Chief Oversight Counsel; Molly Gaston, Counsel; Scott
Schloegel, Investigator; Jennifer Owens, Special Assistant; Paul
Jung, Public Health Service Detailee; Lindsay Vidal, Special As-
sistant; Jen Berenholz, Deputy Clerk; Mitchell Smiley, Special As-
sistant; Matt Eisenberg, Staff Assistant; Alan Slobodin, Minority
Counsel; Krista Rosenthall, Minority Counsel; and Peter Kielty,
Minority Research Assistant.

OPENING STATEMENT OF HON. BART STUPAK, A REPRESENT-
ATIVE IN CONGRESS FROM THE STATE OF MICHIGAN

Mr. Stupak. Today, we have a hearing titled Federal Oversight
of High-Containment Biolabs. The chairman and ranking member
will be recognized for 5-minute opening statements. Other mem-
bers of the subcommittee will be recognized for 3-minute opening
statements.

Nearly 2 years ago, this subcommittee investigated some highly
troubling issues related to high-containment biolabs, which are
labs that handle some of the world’s most exotic and dangerous dis-
eases, including anthrax, smallpox, foot and mouth disease and
Ebola virus.

On October 4, 2007, at a subcommittee hearing titled Germs and
Viruses and Secrets: The Silent Proliferation of Biolabs in the
United States, we focused on increasing the number of high-con-
tainment biolabs, otherwise known as BSL-3 and BSL-4 labs.

The accidental or deliberate release of the dangerous agents han-
dled in those labs could have catastrophic consequences. At our
hearing, we examined whether the Federal Government should be
doing more to keep track of these labs and ensure that they follow
sound safety and security practices.

Since that hearing, important questions have remained alarm-
ingly unanswered, such as, number one, how many high-contain-

( 1 )

ment labs exist in the United States and how many do we really
need; two, how many labs had serious incidents in which lab work-
ers or the public could have been exposed to dangerous diseases;
three, how effective are the high-containment labs’ personnel reli-
ability measures and inventory technology? What changes have
been made to address the Department of Justice’s conclusion that
a single Department of Defense employee caused the anthrax at-
tacks of 2001? We asked the Government Accountability Office,
GAO, to look into these issues, and today we will learn what they
found.

Unfortunately, many problems still exist such as no single agen-
cy or office in the Federal Government keeps track of how many
high-containment labs there are in the United States, where they
are located, what types of research they are doing and whether
they are safe and secure. In short, there still appears to be no ade-
quate Federal plan or effort to manage, much less coordinate, high-
ly dangerous research. There are no universal standards for lab de-
sign, construction, or use.

The Department of Health and Human Services publishes a
guideline. Biosafety in the Biomedical and Microbiological Labora-
tories, known as the BMBL. Labs that receive NIH grants must
comply with BMBL guidelines, but private and other nonfederally
funded facilities have no similar requirement. While labs that han-
dle select agents must obtain Federal registration and certification,
no accreditation or certification is required for labs working with
dangerous organisms that are not on the select agent list, such as
SAKS or West Nile Virus.

There are no standards for biosafety training or the credentialing
of high-containment laboratory workers. The Department of Health
and Human Services only requires training of workers handling or-
ganisms on the select agent list. There are no standards or mecha-
nisms for ensuring involuntary control or personnel reliability.

It is essential to lab security that lab workers undergo adequate
screening and that the quantity of biological agents in a lab is
tracked carefully. Failures in personnel reliability practices can be
catastrophic. Again, the 2001 anthrax attacks, which the Depart-
ment of Justice has said was the work of one Department of De-
fense scientist, is a tragic example of this risk.

Finally, the biolab community has no mechanism to catalogue ac-
cidents and mishaps for collective analysis so lessons can be
learned and shared to improve safety and security practices.

Unfortunately, what is clear is that the Federal policy on bio-
safety and security remains basically unchanged from what it was
when we had our hearing 2 years ago. There is hope that this may
change thanks to two reports that should be finalized hopefully in
the next coming weeks.

The first is the Trans-Federal Task Force on Optimizing Bio-
safety and Biocontainment Oversight, which is cochaired by HHS
and USDA, which was a direct result of our hearing 2 years ago.
The task force report will make important recommendations for im-
proving biosafety in the United States.

Another such study by the Executive Order Working Group on
Strengthening the Biosecurity of the United States, which was ere-

ated by President Bush’s executive order in January, will make rec-
ommendations on ways to improve the select agent program.

The committee staff has been briefed about the process for pre-
paring these reports. It is hoped that these reports will be available
in the next few weeks. I look forward to hearing from the adminis-
tration on this important matter at that time.

Today, we will hear testimony from the Government Account-
ability Office about its findings and recommendations concerning
biolab safety and security. Their report, titled High-Containment
Laboratories: National Strategy for Oversight Is Needed, was re-
leased yesterday. We will also hear from a representative of the
American Society of Microbiology, who can share the perspective of
those who operate and work directly with high-containment labs.
I look forward to hearing the testimony of our witnesses regarding
how we can quickly and responsibly address this challenge and en-
hance our Nation’s biosafety and security.

It is our hope that this new administration will act quickly to ap-
prove data about labs and improve lab safety and security.

Let me also express my condolences to the families and cowork-
ers and friends of the tlniversity of Chicago professor, Malcolm
Casabadan, who died last week from what appears to be an infec-
tion that he may have acquired from the lab while doing research
on the plague. This highlights the fact that even more needs to be
done to protect our scientists and the public inside and outside the
lab.

With that, I will next turn to the gentleman from Oregon, Mr.
Walden, please, for an opening statement.

OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENT-
ATIVE IN CONGRESS FROM THE STATE OF OREGON

Mr. Walden. Thank you. Chairman Stupak. I appreciate the op-
portunity to join you at this hearing today.

I concur with your remarks and sympathies to the family of Mal-
colm Casabadan, and I think it is important to note that this was
a Level 2 lab. We are dealing with Level 3 and 4 in this hearing
today.

But it does raise the issue about how far down we need to go.
And in this case, I guess they are still trying to figure out if the
bacteria. Yersinia, that persisted in his blood that is related to the
plague perhaps caused his death. And so, clearly, we need to be in-
vestigating these safety issues in all of our country’s labs.

I also say, Mr. Chairman, that the Republican staff has come to
learn that the NIH, as part of their stimulus dollars, now may
have received upwards of a billion dollars to more rapidly build out
these labs, which I think raises the issue about our need to do
proper oversight not only of how stimulus dollars are being spent
here but elsewhere throughout the government so the taxpayers’
money is spent appropriately. So I would hope that our sub-
committee would have a hearing on stimulus spending as it relates
to the agencies under our purview.

Yesterday, the Government Accountability Office released a re-
port addressing some of the issues raised at our previous hearing
regarding increased oversight and improved safety measures at

these types of laboratories; and they are here today to discuss their
findings. I appreciate that.

Just weeks after 9/11, our Nation faced a series of bioterrorist at-
tacks where weapons-grade anthrax was delivered through the
mail and five people died. Authorities now believe that one sci-
entist who worked in one of our Nation’s high-containment labora-
tories was responsible for those attacks. My office was in the Long-
worth Building in those days, and we were shut out of our office
because of the anthrax that came into that building.

In response to the attacks. Congress increased funding to up-
grade our Nation’s biodefense program. The National Institutes of
Health, NIH, which funds much of the lab research and construc-
tion, spent $1.7 billion in 2007, compared to $53 million on bio-
defense labs in 2001.

Now, that is a 32-fold increase in spending. Again, we under-
stand that NIH is receiving stimulus dollars to add another billion
dollars in spending for intramural/extramural facilities, and I think
it will be important to note how that money is being spent, espe-
cially with such a steep increase in funding and the rapid expan-
sion of the lab network. It is time to reexamine the Federal regu-
latory system to ensure safety and efficiency.

Our hearing on October 4th of 2007 examined the results of the
Bioterrorism Act on Federal oversight of select agents. It identified
a few gaps and questioned how these labs and Federal regulations
would mitigate risks while increasing our defenses. Now, it has
been almost 2 years since our last hearing, and it is evident both
the Federal Government and the academic realm agreed with the
sense of the subcommittee’s hearing that there is a need for in-
creased oversight and improved safety and security measures in
high-containment laboratories.

As a result of the October 2007 hearing, the Trans-Federal Task
Force on Optimizing Biosafety and Biocontainment Oversight was
created. That is cochaired by HHS and USDA, and their report,
along with recommendations to improve oversight and safety, is
scheduled to be released within the next week or two.

In January, then-President Bush, as you mentioned, Mr. Chair-
man, signed Executive Order 13486 which established the working
group to examine how to strengthen laboratory biosecurity and
safety in our Nation’s high-containment labs. Now, the working
group’s report was completed and sent to the President in July; yet,
to date, the administration has not publicly commented on nor re-
leased the report nor made any formal recommendations. The com-
mittee staff was told the administration has begun to collect and
evaluate these reports and is in the preliminary stages of the policy
process, yet a request for a briefing or a witness for the hearing
from the White House was unanswered.

GAO’s report highlights the pressing need for coordinated na-
tional oversight of our Nation’s high-containment laboratories.
GAO recommends the National Security Adviser name a single en-
tity charged with government-wide strategic evaluation of high-con-
tainment laboratories including tracking our lab capacity, evalu-
ating our country’s needs and establishing our research priorities.

There seems to be some consensus within the scientific commu-
nity that we already have oversight infrastructures in place within

the Department of Health and Human Services and the Depart-
ment of Agriculture. I hope the administration utilizes this existing
expertise instead of creating a centrally located biosafety — or shall
I call it a Germ Czar — at the White House.

Other reports completed by the American Association for the Ad-
vancement of Science and the National Science Advisory Board for
Biosecurity were issued earlier this year. These reports discussed
ways to increase safety and security in our Nation’s high-contain-
ment labs, focusing on personnel reliability and enhancing training
programs. A lot of research and reports have been completed by our
government and academic associations, and we are appreciative of
those, but some of these reports have not been finalized and made
public.

In turn, only Dr. Kingsbury from the GAO is here to discuss
their report — which we appreciate — and answer our questions. But
these facts suggest to me that this committee might have been bet-
ter served by delaying this hearing for a week or two so we could
have all of the reports before us before they were released, and var-
ious responsible Federal agencies could also send witnesses to give
us a more complete view of what we face.

The oversight of our Nation’s high-containment laboratories is an
issue that is deserving of this subcommittee’s attention. However,
this hearing is not inclusive, I believe, or representative of all the
work that has been done in this area, and we need to keep that
in mind as we proceed.

I do want to welcome Dr. Atlas from the American Society of
Microbiology, which has more than 40,000 members. We appreciate
your being here representing the science and health professionals
who staff these labs. Your input will be very valuable.

He will discuss the important roles these laboratories play in
protecting our Nation, the importance of biosafety requirements for
the labs and their personnel, and recommendations to improve bio-
safety training, oversight, resources, reporting, and biosecurity.

Thank you, Mr. Chairman, for holding this hearing. I look for-
ward to working with you on this issue in the weeks ahead.

[The prepared statement of Mr. Walden follows:]

Opening Statement of the Honorable Greg Walden
Ranking Member, Subcommittee on Oversight and Investigations
“Federal Oversight of High Containment Bio-Laboratories”
September 22, 2009

Thank you, Chairman Stupak. I am pleased to join you in continuing
this subcommittee’s investigation into the safety and security issues
surrounding our nation’s high-containment laboratories. These kinds of
facilities are known as bio-safety Level 3 and 4 laboratories, and they
conduct research on highly infectious viruses and other biological agents.
Yesterday, the Government Accountability Office (GAO) released a report
addressing some of the issues raised at our previous hearing regarding
increased oversight and improved safety measures at these laboratories, and
they are here today to discuss their findings.

Just weeks after 9/11, our nation faced a series of bio-terrorist attacks
where weapons-grade anthrax was delivered through the mail. Five people
died. Authorities now believe that one scientist who worked in one of our
nation’s high-containment laboratories was responsible for these attacks.

In response to the attacks. Congress increased funding to upgrade our
nation’s bio-defense program. The National Institutes of Health (NIH),
which fund much of the lab research and construction, spent about $1.7
billion in 2007 compared to spending $53 million on bio-defense labs in
2001. This represents a 32-fold increase in spending. (Recently, Minority
Committee staff was told that some of the money NIH received as part of the
national stimulus package is providing a boost to these high-containment
labs.) With such a steep increase in funding and rapid expansion of the lab
network, it was time to re-examine the federal regulatory^ system to ensure

safety and efficiency. Our hearing on October 4, 2007 examined the results
of the Bioterrorism Act on federal oversight of select agents, identified a few
gaps, and questioned how these labs and federal regulations would mitigate
risk while increasing our defenses.

It has been almost two years since our last hearing and it is evident
that both the federal government and the academic realm agreed with the
sense of the subcommittee’s hearing that there is a need for increased
oversight and improved safety and security measures in high-containment
laboratories.

As a result of the October 2007 hearing, the Trans-Federal Task Force
on Optimizing Bio-safety and Bio-containment Oversight was created, co-
chaired by HHS and USDA, and their report along with recommendations to
improve oversight and safety is scheduled to be released within the next
week or two. In January, then President Bush signed Executive Order 13486
which established a working group to examine how to strengthen laboratory
bio-security and safety in our nation’s high-containment labs. The working
group’s report was completed and sent to President Obama in July. To date,
the Administration has not publicly commented on or released the report or
made any formal recommendations. Committee staff was told that the
Administration has begun to collect and evaluate these reports and is in the
preliminary stages of the policy process, yet a request for a briefing or
witness for the hearing from the White House was unanswered.

GAO’s report highlights the pressing need for coordinated national
oversight of our nation’s high-containment laboratories. GAO recommends
that the National Security Advisor name a single entity charged with
government wide strategic evaluation of high-containment laboratories
including tracking our lab capacity, evaluating our needs, and establishing

our research priorities. There seems to be some consensus within the
scientific community that we already have oversight infrastructures in place
within the Departments of Health and Human Services and the Department
of Agriculture. I hope that the Administration utilizes this existing expertise,
instead of a creating a centrally located Bio-Safety or Germ Czar at the
White House.

Other reports completed by the American Association for the
Advancement of Science and the National Science Advisory Board for Bio-
security were issued earlier this year. These reports discuss ways to increase
safety and security in our nation’s high-containment labs focusing on
personnel reliability and enhancing training programs.

A lot of research and reports have been completed by our government
and academic associations, but some of these reports have not been finalized
and made public. In turn only Dr. Kingsbury from the GAO is here to
discuss their report and answer our questions. These facts suggest to me that
this committee might have been better served by delaying this hearing for a
week or two until all of these reports were released and the various
responsible federal agencies could send witnesses to provide a full
compliment of viewpoints and discuss possible implementation ideas. The
oversight of our nation’s high-containment laboratories is an issue worthy of
this subcommittee’s attention; however this hearing is not inclusive or
representative of all the work that has been done in this area.

1 do want to welcome Dr. Atlas from the American Society for
Microbiology, which has over 40,000 members, who is here as a
representative of the scientists and health professionals who staff these labs.
He will discuss the import role these laboratories play in protecting our
nation, the importance of bio-safety requirements for the labs and its

personnel, and recommendations to improve bio-safety training, oversight,
resources, reporting, and bio-security.

Thank you Mr. Chairman. I want to welcome and thank the witnesses
for testifying today.

Mr. Stupak. Ms. Christensen, opening statement, please?

OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A
REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS

Mrs. Christensen. Thank you, Mr. Chairman, and thank you to
you and Mr. Walden. I really appreciate the opportunity to take a
second look at the lack of oversight on high-containment biolahs.

I recall from my time on the Committee on Homeland Security,
when the National Institute of Allergy and Infectious Disease testi-
fied that they were in the process of building the two laboratories;
and I am amazed to see how the number has grown in the public,
academic and private sectors. But I am very concerned that — as I
am sure are you, that there is no one agency that can tell us how
many of these labs there are, and that some of the same uncertain-
ties about what is exposure, how best to train and certify employ-
ees still exist. Not much seems to have changed since the 2007 re-
port and hearing.

We all realize that we have to balance stimulating and sup-
porting research with providing regulatory oversight, but the ful-
crum really has to be the safety of the employees, the surrounding
communities, and our country.

I look forward to the testimony. I thank Dr. Kingsbury and Dr.
Atlas for being here today.

Mr. Stupak. Mr. Green.

OPENING STATEMENT OF HON. GENE GREEN, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

Mr. Green. Thank you, Mr. Chairman, for holding the hearing
on the Federal oversight of the high-containment biolabs in the
U.S. This hearing is a follow-up one held by our committee in 2007.
I look forward to hearing the testimony from the witnesses on the
Federal oversight of the safety systems of these biolabs and how we
can improve our evaluation and tracking section.

In Texas, the University of Texas Medical Branch at Galveston
National Lab is one of the two national biocontainment laboratories
constructed under grants awarded by the National Institute of Al-
lergy and Infectious Disease, the National Institutes of Health. And
I am proud to have much of this research being performed literally
in the backyard of UTMB at Galveston. At this BSL-4 lab, re-
search is conducted to develop therapies and vaccines and tests for
diseases like anthrax, avian influenza, bubonic plague, Ebola, ty-
phus, West Nile Virus, and tuberculosis. As a Nation, we need this
work performed.

During my visits to UTMB, I learned firsthand about the meas-
ures that UTMB is taking to ensure that that lab is built with
every contingency in mind, and I also learned about the com-
prehensive training program UTMB has in place.

I have a personal interest in the safety of biolabs because my
daughter completed her fellowship at UTMB, and she worked some
of the research conducted on the select agents at the operational
BSL-4 and in that Galveston National Lab when it was completed.
Due to the damage to the UTMB campus from Hurricane Ike, she
unfortunately left Galveston, and now she is at the University of
Nebraska working in infectious diseases.

But I also know that during Hurricane Ike that lab was the
safest place to be on the Galveston Island. There was no loss, no
exposure, and just a success on what had been done for a number
of years; and the center grew even more. It withstood a Category
4 hurricane on a barrier island, so I think it is built pretty well.

As a parent to a researcher, I want to make sure that these bio-
safety labs adhere to higher safety training standards wherever
they may be; and it was a source of personal comfort that UTMB
had placed such an emphasis on safety training, safety of these
labs across the U.S. Given the growth of these labs nationwide, I
think we need to step up our safety training efforts, as well as
structure within the existing agency, such as HHS or the Depart-
ment of Agriculture, to track the growth of these labs.

I appreciate the witnesses here today. And my other hat, I serve
on the Health Subcommittee, and a lot of those illnesses that these
biolabs are working on are ones that we hope to be able — we hope
they will never have to treat our constituents. But we also know
in this world they may have to, so we need those labs here, doing
their job.

Mr. Stupak. For other members — and I know Chairman Wax-
man and others have submitted opening statements — their state-
ments will be made part of the record.

[The prepared statements of Messrs. Dingell, Markey, Barton,
and Burgess follow:]

Subcommittee on Oversight and Investigations
Hearing on “Federal Oversight of High Containment Bio-Laboratories”
Opening Statement of the Honorable John D. Dingell
September 22, 2009

Chairman Stupak, thank you for holding this hearing today on the challenges of and the
need for providing oversight of high containment, also known as biosafety level (BSL)-3
and BSL 4, bio-laboratories in the United States. I am pleased the Committee is
continuing its investigation into the world of high containment bio-laboratories that
began in 2007. I also want to thank our witnesses, who provided useful insights and
recommendations from which the Congress can determine the need for legislative action.

It is clear that high containment bio-laboratories are not only important for basic research
of infectious diseases, but especially after September 1 1 and the anthrax attacks of 2001,
they are a necessary component of our national effort to combat biological terrorism.
However, in light of the Government Accountability Office (GAO) Report released
yesterday and the testimony we will hear today, there is still an unsettling gap in federal
oversight of high containment labs, which perform research on dangerous pathogens and
emerging infectious diseases. For example, GAO testimony states there is no federal
agency that is knows the total number nor whose mission is to track the expansion of high
containment laboratories. Thus, it is unclear whether we have a too few, enough, or too
many of these laboratories in the U.S. Further, there is no national personnel training
requirement for workers, personnel reliability standards to counter insider threats, nor is
there a design, construction, and maintenance standard for these laboratories.

I would like to highlight one particular incident in the GAO report which relates to
concerns I have expressed regarding the handling and research of Foot and Mouth
Disease, a highly infectious animal disease. GAO reports that an accidental release of
Foot and Mouth Disease in the United Kingdom was likely caused by poor maintenance
of a bio containment facility coupled with a lack of clear lines of responsibility regarding
the maintenance of shared infrastructure facilities. That outbreak caused U.K. taxpayers
over $3 billion. The incident underscores some of the dangers about the proposed
National Bio- and Agro- Defense (NBAF) Laboratory to be constructed in Manhattan,
Kansas, which will house research of FMD. Any release of FMD, whether an intentional
insider release or accidentally caused by human error, poor construction or maintenance,
could cause tens of billions of dollars in damage to our domestic livestock industty'. The
gaps identified in the GAO report regarding the lack guidelines for design, construction,
maintenance, personnel reliability, and worker training further illustrate that we must be
extremely cautious in deciding whether to build the NBAF in Kansas or any other high
containment laboratories in the U.S.

I look forward to hearing our witness testimony which will help this Committee and the
Congress best determine the next steps for oversight of high containment bio laboratories
in the U.S.

Statement of Rep. Edward J. Markey
Oversight and Investigations Subcommittee Hearing on

Federal Oversight of High Containment Bio-Laboratories

September 22, 2009

Thank you, Mr. Chairman, for holding today’s hearing on the
government’s oversight, or lack thereof, of high containment
biological laboratories.

First of all, I would like to say that I am a longstanding supporter
of biomedical research. I believe that medical research allows us to
harvest cures from science’s field of dreams, reaping enormous
benefits for our society. Biomedical research that is conducted
safely and ethically improves human health, strengthens our
economy, and ultimately, saves lives.

Since the tragic anthrax attacks of 2001 , our nation’s research
community has geared up to better prepare us against the very real
threat of biological agents. The Bush administration increased
research funds, workforce size, and the overall number of
laboratories to go to battle against these agents. But they made
these increases without a coordinated plan of attack, without
keeping track of their work, and without mechanisms to evaluate
their progress. That’s like hitting the field for a football game
without a playbook! They were unprepared and uncoordinated and
this led to serious problems.

We learned in the last hearing on biolab safety in this
subcommittee that our nation’s biological laboratories are fraught
with security and safety problems, endangering the safety and
well-being of Americans who live in the vicinity of these
laboratories. And recent revelations that the 2001 anthrax attacks
were carried out by a scientist at a federal government laboratory
raise additional questions about how effectively the government
can oversee facilities it doesn’t own or operate itself

One of the newest high containment facilities is being built by
Boston University in my home state, right in downtown Boston.
This facility will include laboratories classified as Biosafety Level
4 , which means that it will contain pathogens that have no cure,
like the Ebola virus and the plague.

As you can imagine, some residents of Boston were not too
pleased to have the plague right in their backyard, even though it is
contained is a facility that’s designed to be extremely secure. And
imagine how they felt when the National Academies announced
that the safety review conducted by Boston University was grossly
inadequate, not scientifically sound, and not credible.

Thankfully, the former director of the NIH, Dr. Elias Zerhouni,
intervened and pulled together a blue ribbon panel of science and
safety experts to complete a thorough evaluation of the safety of
the Boston lab.

The problems with the safety evaluation of the Boston University
lab highlight the need for national coordination, planning, and
oversight of high containment bio-labs. I look forward to today’s
testimonies and I hope that the GAO’s recommendations are
adopted by the time the Boston lab opens up next year.

Opening Statement of the Honorable Joe Barton
Ranking Member, Committee on Energy and Commerce

Subcommittee on Oversight and Investigations Hearing:

“Federal Oversight of High Containment Bio-Laboratories”
September 22, 2009

Thank you. Chairman Stupak and Ranking Member Walden, for holding this
hearing. This is our second hearing on the safety and security at our nation’s high-
containment laboratories. It has been almost two years since our initial hearing, and I
look forward to hearing what actions have been taken by the federal government and the
private sector to address some of the issues we raised at our last hearing to improve the
safety and security at these labs.

In response to 9-1 1, the anthrax attacks, and the emerging threat of bio-terrorism,
Congress passed the Bioterrorism Act in 2002. Among other things, this Act established
a regulatory system at the Centers for Disease Control over the possession, use, and
transfer of select agents and toxins. We also dramatically increased spending for
building and expanding laboratories that research deadly germs and toxins. With
increased funds and new regulations, high containment laboratories’ safety and security
and personnel assurance measures were re-evaluated. These labs have to maintain a
robust research agenda while simultaneously protecting the public and their own workers
from the inherent dangers involved in researching dangerous pathogens. Strict safety
rules and guidelines are required to protect against leaks, losses, or theft of these deadly
materials.

This hearing re-examines several issues raised at our 2007 hearing. The
Government Accountability Office issued a report yesterday once again highlighting the
need for improved and coordinated federal oversight of high containment laboratories.
Several other reports have either been issued or are about to be released. These include
reports by the National Science Advisory Board for Bio-security and the American
Association for the Advancement of Science, as well as a report by the Trans-Federal
Task Force on Optimizing Bio-safety and Bio-containment Oversight. In addition,
former President Bush signed Executive Order 13486 in January which established a
working group to examine how to strengthen laboratory bio-security and safety in our
nation’s high-containment labs. The working group’s report was completed and sent to
President Obama in July. To date, the Administration has not publicly commented on the
report or recommendations. Committee staff contacted the National Security Council
and requested a briefing and or testimony for today’s hearing, but no response was given.

Over the past two years, it appears that invested parties from the government and
academia have been examining ways to increase oversight and safety. Congress and the
President need to work together to develop a policy that is both protective of the public
health as well as conducive to maintaining a strong network of high-containment labs and
scientists.

While we discuss the possible gaps in federal and institutional oversight of high
containment laboratories, we should also realize that the work performed in these high-
risk laboratories is critical to our nation’s defense and health. Dedicated scientists and
lab staff conduct truly critical research into bio-defense and vaccines in these labs. One
day, the work they do may save the lives of millions. One of our witnesses today is Dr.

Atlas from the American Society for Microbiology. He will offer a valuable perspective
as a representative of those who work in the field.

I believe that the government, the private sector, and universities can figure out
how to conduct research into the agents of bioterrorism and that they can also figure out
how to protect lab workers and the public at the same time. Our country needs both of
those jobs done, and done well.

Thank you, Mr. Chairman. I welcome all the witnesses.

STATEMENT OF

CONGRESSMAN MICHAEL C. BURGESS, M.D.
BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
COMMITTEE ON ENERGY AND COMMERCE

SEPTEMBER 22, 2009 HEARING
“Federal Oversight of High Containment Bio-Laboratories”

For several weeks now, I have been awaiting an O&I hearing my
good friend Bart Stupak had noticed regarding moving bio-security
research from Plum Island inland. I’m not sure what Speaker
Pelosi is doing but instead of giving Bart a hearing on Plum Island
like he noticed, we get a hearing on bio-laboratories as a whole.

And what did we get from the delay in timing and overbroad topic?

Nothing. This hearing can hardly be considered well thought-out
and executed.

On September 15, 2009 we had a vote on H. Res. 317 recognizing
Kansas as the appropriate state for the National Bio and Agro-
defense Facility, with the language of the resolution proudly
touting that 45% of the fed cattle in the United States and 40% of
the hogs produced in this country are in Kansas. Considering that
food-and-mouth disease, which is the primary research being done
at Plum Island, is a disease which can spread with devastating
swiftness from humans to cattle and hogs ... shouldn’t we have
done our O&I hearing on the scientific evaluations being done at
DHS before we voted on a resolution saying that Kansas was the
best pick?

In fact, the GAO stated that foot-and-mouth disease research
shouldn’t be moved inland for this very reason — and certainly not
to an area with lots of cattle and hogs!

I’m glad I voted against that resolution for that very reason. We
need to have some common sense here in Congress.

Also, what is Nancy Pelosi doing putting forth an O&I hearing on
an issue which touches DHS, USDA, HHS, CDC and The White
House’s NSA - not to mention the private sector - with one
witness from the GAO and one witness from the private sector and
no one from the federal government?

We already have an Executive Working Group on this very topic
who, in July, sent to President Obama a report on “Strengthening
the Bio-security of the United States’’ as well as a Trans-Federal
Task Force on “Optimizing Bio-safety and Bio-containment
Oversight.”

Why could we not have had these reports paneled before us today
and not just the GAO??

Our committee is not a classroom for mere esoteric discussion and
thought. We are not interested in purely academic conversation
about omnibus changes to an issue which clearly has simply been
suffering from merely a lack of communication and basic
oversight.

For instance, today’s GAO report states that twelve federal
agencies play a role in our biodefense, but information about what
they are doing are unknown. Why is this? Don’t these federal
agencies have phones and emails? Can’t they just go and have
meetings with each other and tell them what they are doing? Why
do they need a Biodefense CZAR on top of DHS and The White
House to coordinate information?

I am deeply disturbed by the notion put forth by the GAO that
there needs to be YET ANOTHER layer of oversight for our

federal government when it comes to our homeland security. After
all, we have given them the legal authority under BARDA and tens
of billions of dollars of hard-earned taxpayer dollars to function . If
they aren’t functioning, then we need to have them here and held
accountable.

Thank you.

Mr. Stupak. That concludes the opening statements by members
of the committee. I now call our witnesses.

On our panel we have Dr. Nancy Kingsbury, who is the Man-
aging Director of Applied Research and Methods at the U.S. Gov-
ernment Accountability Office; Dr. Sushil Sharma with the GAO;
and Dr. Ronald Atlas, who is the cochair of the Committee on Bio-
defense at the American Society for Microbiology.

STATEMENTS OF NANCY KINGSBURY, Ph.D., MANAGING DI-
RECTOR, ACCOMPANIED BY SUSHIL SHARMA, ASSISTANT DI-
RECTOR, APPLIED RESEARCH AND METHODS, U.S. GOVERN-
MENT ACCOUNTABILITY OFFICE; AND RONALD M. ATLAS,

Ph.D., CO-CHAIR, COMMITTEE ON BIODEFENSE, AMERICAN

SOCIETY FOR MICROBIOLOGY

Mr. Stupak. Welcome to our witnesses.

It is the policy of this subcommittee to take all testimony under
oath. Please be advised that you have a right under the rules of
the House to be advised by counsel during your testimony. Do you
wish to be represented by counsel?

Everyone is indicating “no.”

All right. Then I am going to ask you to please rise, raise your
right hand and take the oath.

[Witnesses sworn.]

Mr. Stupak. The witnesses replied in the affirmative.

We will hear a 5-minute opening statement from our witnesses.
You may also submit a longer statement, and it will be in the
record.

STATEMENT OF NANCY KINGSBURY, Ph.D.

Ms. Kingsbury. Mr. Chairman and members of the sub-
committee, we are very pleased to be here to discuss our report on
the national strategy for high-containment laboratories in the
United States that deal with dangerous pathogens. Our report on
those matters was released yesterday, as you mentioned in your
opening statements.

Such high-containment laboratories have proliferated in recent
years. This report focuses on the proliferation in the West, but
similar things are done in other countries.

In 2007, we reported on several issues associated with the pro-
liferation of these labs in the United States and some of these risks
posed by biosafety incidents that occurred in the past. The FBI’s
allegation in August 2008 that a DOD scientist was the sole perpe-
trator of the 2001 anthrax attacks raised additional concerns about
the possibility of insider misuse of high-containment lab facilities,
materials and technology. Highly publicized laboratory errors and
controversies about where high-containment labs should be located
had raised questions about whether the governing framework,
oversight and standards for biosafety and biosecurity are adequate.

In this context you asked us to address the following questions:

To what extent and in what areas has the number of high-con-
tainment labs increased in the United States?

Which Federal agency is responsible for tracking the expansion
of high-containment laboratories in determining the associated ag-
gregated risks?

And what lessons can be learned from highly publicized incidents
at high-containment laboratories and actions taken by the regu-
latory agencies?

We have three basic findings to report:

First, since 2001 the number of BSL-3 and BSL-4 labs in the
United States has increased, and this expansion has taken place
across Federal, State, academic and private sectors. Information
about the number, location, activities and ownership is available
for high-containment laboratories that are registered with CDC’s or
USDA’s select agent programs, but not for those outside those pro-
grams.

The expansion that began after the anthrax attacks in 2001
lacked a clear, coordinated national strategy. Decisions to fund con-
struction of high-containment labs were made by multiple Federal
agencies in multiple budget cycles. Federal and State agencies, aca-
demia and the private sector considered their individual require-
ments, but an assessment of national need was lacking. Even now,
after more than 7 years, we were unable to find any projections
based on a government-initiated strategic evaluation of current and
future capacity requirements linked to national public health goals.
Such information is needed, we think, to ensure that the U.S. will
have facilities in the right place with the right research capabili-
ties.

Second, no executive or legislative mandates directs any single
Federal agency to track the expansion of all high-containment labs.
Accordingly, no Federal agency knows how many such labs exist in
the United States and no single agency is responsible for deter-
mining or are able to determine the aggregate risks associated with
the expansion of these labs. Consequently, no Federal agency can
determine whether high-containment lab capacity is now less than,
meets or exceeds the national need.

Finally, four highly publicized biosafety incidents in high-con-
tainment labs, as well as evidence in scientific literature, dem-
onstrate that while laboratory accidents are rare, they do occur,
primarily due to human error or systems failures.

One of the incidents we reviewed involved the allegations that
Dr. Bruce Ivins of DOD was the source of the 2001 anthrax attack.
These allegations highlighted two lessons: First, an ill-intentioned
insider could pose a risk by removing dangerous material from a
high-containment lab; and second, it is impossible to have 100 per-
cent effective inventory control of biological material with currently
available technologies. Such inventory control is possible for nu-
clear material and for chemical material, but because biological
material grows and expands, there are currently no available tech-
nologies.

At Fort Detrick, USF procedures for the control of inventories
and the unrestricted use of lab facilities allegedly allowed Dr. Ivins
the opportunity to pursue his own ends. As the number of high-con-
tainment labs increases, there will inevitably be an increase in the
pool of scientists with expertise, and thus, the corresponding risk
from insiders is likely to increase.

Taken as a whole, these incidents we reviewed demonstrate fail-
ure of systems and procedures meant to maintain biosafety in high-
containment labs. They reveal the failure to comply with regulatory

requirements that were not commensurate with the level of risk to
public health posed by the lab workers and the pathogens in the
lab, and the failure to fund ongoing facility maintenance and mon-
itor the operational effectiveness of lab physical infrastructure.

In conclusion, I want to stress that oversight plays a critical role
in improving biosafety and ensuring that high-containment labs
comply with regulations. However, some aspects of the current
oversight programs provided by the CDC and USDA are dependent
upon entities monitoring themselves and reporting incidents to
Federal regulators.

Furthermore, personnel reliability programs have been estab-
lished by 2001 to counter insider risks, but their cost, effectiveness
and problematic impact has not been evaluated.

If an agency were tasked or a mechanism were established with
the purpose of overseeing the expansion of high-containment labs,
it could develop a strategic plan to ensure that the number and ca-
pabilities of potentially dangerous high-containment labs are no
greater or no less than necessary. It could balance the risks and
benefits of expanding such labs and it could determine the type of
oversight needed.

To address these issues we recommended that the National Secu-
rity Adviser, in consultation with the Secretaries of Health and
Human Services, Agriculture, Defense, and Homeland Security,
and the National Intelligence Council and any other departments
and agencies that are appropriate, identify a single entity charged
with periodic strategic evaluation of high-containment labs that
will determine the number, location and mission of laboratories
needed to effectively meet national goals to counter biothreats, the
existing laboratory capacity within the United States, the aggre-
gate lists associated with the expansion and the type of oversight
needed.

It could also develop in consultation with the scientific commu-
nity national standards for the design, construction, commissioning
and operation of high-containment laboratories, specifically includ-
ing provisions for long-term maintenance, which is an area that we
are quite concerned about.

We also recommended that the Secretaries of Health and Human
Services and Agriculture develop a clear definition of exposure to
select agents — some of these incidents suggest that there is some
confusion in that regard — and a mechanism for sharing lessons
learned from reported laboratory accidents so that best practices
for other operators for high-containment laboratories can be identi-
fied and distributed.

Recognizing that biological inventories cannot be completely con-
trolled at present, we also recommended that the Secretaries of
HHS and Agriculture review existing inventory control systems
and invest in and develop appropriate technologies to minimize the
potential for insider misuse of biological agents.

Finally, should the Secretaries consider implementing a more
stringent personnel of liability program for high-containment lab-
oratories, employees to deal with insider risks, we recommended
that they evaluate and document the cost effectiveness and pro-
grammatic impact of such a program.

We did obtain written comments on the draft of our report from
the Secretaries of Health and Human Services and Agriculture.
HHS and Agriculture concurred with our recommendations that
were directed to them. The Executive Office of the President and
the National Security Council did not provide any comments.

Mr. Chairman, this concludes my prepared remarks, and I will
be happy to answer any questions that you or your colleagues may
have.

Mr. Stupak. Thank you.

[The prepared statement of Ms. Kingsbury follows:]

GAO

United States Government Accountability Office

Testimony

Before the Subcommittee on Oversight
and Investigations, Committee on Energy
and Commerce, House of Representatives

For Release on Delivery

Expected at 11:00 a.m. EDT
Tuesday, September 22, 2009

HIGH-CONTAINMENT

LABORATORIES

National Strategy for
Oversight Is Needed

statement of Nancy Kingsbury, Ph.D.

Managing Director

Applied Research and Methods

A GAO

Accountability * Integrity * Reliability

GAO-09-1036T

Mr. Chairman and Members of the Subcommittee

We are pleased to be here to discuss our report on a national strategy for
high-containment laboratories that deal with dangerous pathogens — also
known as biosafety Ievel-3 (BSL-S) laboratories and biosafety level-4 (BSL-
4) laboratories — in the United States, which was released yesterday. ‘ The
number of high-containment laboratories working with dangerous
biological pathogens have proliferated in recent years. In 2007, we
reported on several issues associated with the proliferation of high-
containment laboratories in the United States, including risks posed by
biosafety incidents that have occurred in the past.^ The Federal Bureau of
Investigation’s allegation in August 2008 that a scientist at the U.S. Army
Medical Research Institute of Infectious Diseases was the sole perpetrator
of the 2001 anthrax attacks raised additional concerns about the
possibility of insider misuse of high-containment laboratory facilities,
material, and technology. The public is concerned about these laboratories
because the deliberate or accidental release of biological agents can have
disastrous consequences by exposing workers and the public to dangerous
pathogens. Highly publicized laboratory errors and controversies about
where high-containment laboratories should be located have raised
questions about whether the governing framework, oversight, and
standards for biosafety and biosecurity measures are adequate.® In this
context, you asked us to address the following questions; ‘

1. To what extent, and in what areas, has the number of high-
containment laboratories increased in the United States?

2. Which federal agency is responsible for tracking the expansion of high-
containment laboratories and determining the associated aggregate
risks?

‘ GAO, High-ContainiTtmt Laboratories: National Strategy for Oversight Is Needed.
GAO-09-574 (Washington, D.C.: Sept 21, 2009).

^GAO, High-Containment Biosafety Laboratories: Preliminary Observation on the
Oversight of the Proliferation of and BSL-4 Laboratories in the United States,

(iAO-Oa-lOST (Washington, D.C.: Oct 4, 2007).

®G.K. Gronv^ et al., “Letter to Senator Edward Kennedy and Senator Richard Burr,"
Center few BirKecurity, University of Pittsburgh Medical Center, March 3, 2009.

■*The reque^ letter contained several questions. In agreement with our requestor, we
revised the questions as stated.

Page i

GAO-09-1036T

3. What levins can be learned from highly publicized incidents at high-
containment laboratories and actions taken by the regulatory
agencies?

To answer these questions, we interviewed federal agency officials as well
as experts in microbiology, reviewed literature, conducted site visits, and
surveyed 12 federal agencies to determine if they have a mission to track
high-containment laboratories in the United States. We also interviewed
officials from relevant intelligence agencies to determine if they have a
mission to determine insider risks in high-containment laboratories. The
expert panel that reviewed this report comprised scientists witli
substantive expertise in microbiological and select agent research and the
operation of high-containment laboratories.

We conducted our work from September 2005 through June 2009 in
accordance with generally accepted government auditing standards. Those
standards require that we plan and perform the audit to obtain sufficient,
appropriate evidence to provide a reasonable basis for our findings and
conclusions based on our audit objectives. We believe that the evidence
obtained provides a reasonable basis for our findings and conclusions
based on our audit objectives.

The Number of High-
Containment
Laboratories Is
Increasing in
Different Sectors
throughout the United
States

We found that since 2001, the number of BSLr4 and BSL-3 laboratories in
the United States has increased, and this expansion has taken place across
federal, state, academic, and private sectors and throughout the United
States. Federal officials and experts believe that while the number of BSL-
4 laboratories in the United States is known, the number of BSL-3
laboratories is unknown. Information about the number, location,
activities, and ownership is available for high-containment laboratories
that are registered with the Centers for Disease Control and Prevention’s
(CDC) Division of Select Agents and Toxins (DSAT) or the United States
Department of Agriculture’s (USDA) Animal and Plant Health and
Inspection Service (APHIS) select agent programs, but not for those
outside the program. The recent expansion of high-containment
laboratories in the United States began in response to the need to develop
medical countermeasures and better risk evaluations after the anthrax
attacks in 2001. Understandably, the expansion initially lacked a clear,
govemmentwide coordinated strategy. In that emergency situation, the
expansion was based on individual agency perceptions of requirements
relative to the capacity their high-containment labs required as well as the
availability of congressionaliy appropriated funding. Decisions to ftmd the
construction of high-containment labs were made by multiple federal

Page 2

GAO-09-I036T

agencies in multiple budget cycles. Federal and state agencies, academia,
and the private sector considered their individual requirements, but an
assessment of national needs was lacking. Even now, after more than 7
years, GAO was unable to find any projections based on a
govemmentwide strategic evaluation of future capacity requirements set
in light of existing capacity; the numbers, locations, and missions of the
laboratories needed to effectively counter biothreats; and national public
health goals. Such information is needed to ensure that the United States
will have facilities in the right place with the right specifications.

No Federal Agency
Has the Mission to
Track the Expansion
of All High-
Containment
Laboratories and
Regulate Biosafety in
the United States

Currently, no executive or legislative mandate directs any federal agency
to track the expansion of all high-containment laboratories. Because no
federal agency has the mission to track the expansion of BSL-3 and BSL-4
laboratories in the United States, no federal agency knows how many such
laboratories exist in the United States. While there is a consensus among
federal agency officials and experts that some degree of risk is always
associated with high-containment laboratories, no one agency is
responsible for determining, or able to determine, the aggregate or
cumulative risks associated with the expansion of these high-containment
laboratories. As a consequence, no federal agency can determine whether
high-containment laboratory capacity may now meet or exceed the
national need or is at a level that can be operated safely.

Lessons Learned from
Four Incidents
Highlight the Risks
Inherent in the
Expansion of High-
Containment
Laboratories

Four highly publicized incidents in high-containment laboratories, as well
as evidence in the scientific literature, demonstrate that (1) while
laboratory accidents are rare, they do occur, primarily because of human
error or systems (management and technical operations) failure, including
the failure of safety equipment and procedures; (2) insiders can pose a
risk; and (3) it is difficult to control inventories of biological agents with
currently available technologies. It has been suggested that personnel
reliability programs would mitigate the insider risk. The National Science
Advisory Board for Biosecurity reported that there is little evidence that
personnel reliability measures are effective or have predictive value in
identifying individuals who may pose an insider risk. (4) Continuity of
electrical power is vital for the safe functioning of high-containment
laboratories, in particular since maintenance of essential pressure
differentials using electrically driven fans provides an important barrier
for preventing the uncontrolled release of agents.^ Lapses in electrical
power that occurred at a CDC laboratory raise concerns about standards
in high-containment laboratory facility design, management of
construction, and operations.

Pages

GAO-09-1036T

Taken as a whole, these incidents demonstrate failures of systems and
procedures meant to maintain biosafety in high-containment laboratories.
For example, they revealed the failure to comply with regulatory
requirements, safety measures that were not commensurate with the level
of risk to public health posed by laboratory workers and pathogens in the
laboratories, and the failure to fund ongoing facility maintenance and
monitor the operational effectiveness of laboratory physical infrastructure.

Conclusions

Oversi^t plays a critical role in improving biosafety and ensuring that
high-containment laboratories comply with regulations. However, some
aspects of the current oversight programs provided by the Departments of
Health and Human Services and Agriculture are dependent upon entities
monitoring themselves and reporting incidents to federal regulators. Since
2001, personnel reliability programs have been established to counter
insider risks, but their cost, effectiveness, and programmatic impact have
not been evaluated.

In conclusion, proliferation of high-containment laboratories is taking
place in all sectors. FXirthermore, since no single agency is in charge of the
current expansion, no one is determining the associated aggregate risks
posed by the expansion. As a consequence, no federal agency can
determine whether high-containment laboratory capacity may now be less
than, meet, or exceed the national need or is at a level that can be
operated safely.

If an agency was tasked or a mechanism was established with the purpose
of overseeing the expansion of high-containment laboratories, it could
develop a strategic plan to (1) ensure that the number and capabilities of
potentially dangerous high-containment laboratories are no greater or less
than necessary, (2) balance the risks and benefits of expanding such
laboratories, and (3) determine the type of oversight needed.

Such an agency or mechanism could anal 3 ^e the biothreat problems that
need to be addressed by additional BSL-3 and -4 laboratories, the scientific
and technical capabilities and containment features that such laboratories
need to have, how the laboratories should be distributed geographically,
and how the activities of the laboratories would be coordinated to achieve
intended goals. The agency or mechanism responsible for overseeing the
expansion of high-contairunent laboratories could also be responsible for
coordinating with the scientific community to develop guidelines for high-
containment laboratory design, construction, and commissioning and
training standards for laboratory workers; providing definitions for

GAO-09-1036T

exposure; developing appropriate inventory control measures; and
providing guidance on tiie most efficient approach to personnel reliabOity
programs.

Overall, the safety record of high-containment laboratories has been good,
although a number of weaknesses have become apparent over time.
Consequently, along with expansion there needs to be a commensurate
development of both operational and oversight procedures to address
known deficiencies and, as far as practicable, proactively evaluate future
risks.

Laboratoiy operators, in collaboration with regulators, need to develop
and work through potential failure scenarios and use that information to
develop and put in place mechanisms to challenge procedures, systems,
and equipment to ensure continuing effectiveness.

R6C0niinGnd3.ti0nS for address these issues, we recommended that the National Security
Advisor, in consultation with the Secretaries of Health and Human
Executive Action services (HHS), Agriculture, Defense (DOD), and Homeland Security

(DHS); the National Intelligence Council; and other executive departments
as deemed appropriate identify a single entity charged with periodic
govemmentwide strategic evaluation of high-containment laboratories
that will

(1) determine

• the number, locations, and mission of the laboratories needed to
effectively meet national goals to counter biothreats,

• the existing capacity within the United States,

• the aggregate risks associated with the laboratories' expansion, and

• the type of oversight needed, and

(2) develop, in consultation with the scientific community, national
standards for the design, construction, commissioning, and operation of
high-containment laboratories, specifically including provisions for long-
term maintenance.

We recommended that the Secretaries of HHS and USDA develop (1) a
clear definition of exposure to select agents and (2) a mechanism for
sharing lessons learned from reported laboratory accidents so that best
practices — for other operators of high-containment laboratories — can be
identified.

Page 5

GAO-09-1036T

Should the Secretaries consider implementing a personnel reliability
program for high-containment laboratories to deal with insider risk, we
recommended that they evaluate and document the cost, effectiveness,
and programmatic impact of such a program.

Recognizing that biological agent inventories cannot be completely
controlled at present, we also recommended that the Secretaries of HHS
and USDA review existing inventory control systems and invest in and
develop appropriate technologies to minimize the potential for insider
misuse of biological agents.

Agency Comments
and Our Evaluations

We obtained written comments on a draft of our report from the

Secretaries of HHS and USDA. The Executive Office of the President:
National Security Council did not provide comments. HHS and USDA
concurred with our recommendations that were direcled to them.

Mr. Chairman, this concludes my prepared remarks. I would be happy to
respond to any questions that you or other members of the subcommittee
may have at this time.

Contact and
Acknowledgments

If you or your staffs have any questions about this report, please contact
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Offices of Congressional Relations and Public Affairs may be found on the
last page of this statement. Amy Bowser, George Depaoli, Terrell Dorn,

Jeff McDermott, Jean McSween, Jack Melling, Ph.D., Corey Scherrer,

Linda Sellevaag, and Elaine Vaurio made key contributions to this
testimony.

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Mr. Stupak. Dr. Atlas, opening statement, please, sir.

STATEMENT OF RONALD M. ATLAS, Ph.D.

Mr. Atlas. Thank you, Mr. Chairman, members of the sub-
committee. I want to thank you for the opportunity to testify on be-
half of the American Society for Microbiology.

When I began my career 40 years ago, we thought we had con-
quered infectious diseases, but in fact that is not the case. We have
newly emerging infectious diseases every year, whether it is SARS
or multidrug and extremely drug-resistant tuberculosis or the re-
current outbreak of the HlNl influenza. And these outbreaks of
disease have not only public health but also economic and political
repercussions, and therefore we need to carry out research to find
the therapeutic vaccines, diagnostics and other ways of coping with
these diseases.

In other words, we must continue to perform research on patho-
genic microorganisms, and much of that research needs to be per-
formed in high-containment laboratories where the safety of the
scientists working on the organisms, as well as the public, can be
protected. These are not weapons laboratories; rather, they are re-
search laboratories where investigations are carried out with the
aim of protecting public health.

Inevitably, as we have seen in the tragic case in Chicago, at least
from the reports, there is risk to the scientists and perhaps to the
community when we work with these organisms. And accordingly,
the American Society for Microbiology has strongly supported re-
sponsible regulation, oversight, practices and guidelines that im-
prove laboratory biosafety and protect laboratory personnel, the
public and the efficacious performance of the research that leads to
vaccines, therapeutic drugs and diagnostics that we need. And over
the years we have reached a balance, at least for the moment, be-
tween the safety practices that are carried out in the laboratory
and the ability to perform research.

Although these procedures, when properly followed, do provide a
level of safety to the workers in the community, the ASM feels that
we continuously need to review these practices and to find new and
better ways to move forward.

During the past 2 years, the ASM has met with the Trans-Fed-
eral Task Force on Biosafety and Biocontainment Oversight and
the Executive Order Working Group on strengthening the biosecu-
rity of the United States and made a number of recommendations
to those groups. Clearly, there is a need to ensure adequate train-
ing and strict compliance to provide the levels of protection engen-
dered in existing biosafety procedures, as well as those that may
be proposed.

The ASM has made a number of recommendations which I would
like to summarize for you.

First, the Biosafety and Microbiological and Biomedical Labora-
tories Manual, or the BMBL, which contains the core guidelines for
the safe operation of all microbiological laboratories, should be the
subject of regular biennial review and update, as needed. The
BMBL, along with the NIH guidelines for recombinant DNA re-
search, are essential reference documents. We need to continuously
examine these, update them, and provide more guidance for the

community and to develop specific competencies for biosafety train-
ing and recommended procedures for incident reporting. The ASM
view is that the CDC, NIH, and USDA should take the lead for
BMBL revisions, but there should be input through from the com-
munity.

Second, the list of pathogens designated as select agents and
those requiring BSL-3 and BSL-4 containment should be regularly
updated; and again, we would urge that a scientific community
that is broadly based help to guide the development of these lists.

Third, there should be mandated training and performance re-
quirements for biosafety personnel overseeing the safety of high-
containment laboratories. And again, the NIH and CDC should
make educational training programs available, and we should con-
tinuously look to the standards that need to be achieved.

Fourth, the select agent regulation should be revised to change
the requirements for inventory of vials and select agents. Labora-
tories should be accountable for which agents they possess and
where these agents are located, but counting of vials that are in
a freezer when we are dealing with live organisms provides a false
sense of security and does not really help in protecting the Nation.

Fifth, the NIH requirements that foreign institutions must have
comparable facilities and standards that are U.S. Collaborative
should be changed to remove hurdles for international collabora-
tion. We have been struck by the UTMB experience where they no
longer can get strains of hemorrhagic fever viruses into the United
States because the laboratories overseas that, in fact, are holding
those organisms may not meet U.S. standards.

Six, the Congress should enhance funding, as needed, to ensure
the upkeep of the high-containment laboratories. Now that many
of these laboratories have been constructed, they should be con-
cerned that they continue to meet the high standards to which they
were built.

Seven, we need an improved system for surveillance and report-
ing of laboratory-acquired illnesses. This should be done in a way
where we learn lessons from incidents which, unfortunately, occur
rather than trying to hide these incidents for fear of recrimination.

And finally, we should be examining very carefully the costs and
benefits of potential accreditation systems. In this regard, we see
the current select agent regulations as providing a
pseudoaccreditation. There are standards, there are inspections; as
has been pointed out, this does not exist for the nonselect agents,
and I think we need to examine the potential value of moving for-
ward.

We would note that the American Biological Safety Organization,
ABSA, is in fact in the process of developing a voluntary accredita-
tion system. I think we need to look at that. But moreover, we real-
ly need to develop the standards and look to what we need to hold
the labs accountable for and have a system in place where we can
assure this committee and the Nation that we are complying.

In conclusion, I think we have made tremendous strides over the
past years in moving towards meeting the needs of the Nation both
in terms of the research and the safety. More needs to be done. We
need to do this carefully and in a considerate way, so we don’t
upset an apple cart and put the Nation at risk.

Thank you, Mr. Chairman, and I look forward to your questions.
[The prepared statement of Mr. Atlas follows:]

AMERICAN
SOCIETY FOR

MICROBIOLOGY Public and Scientific Affairs Board

American Society for Microbiology's testimony before the Committee on Energy
and Commerce Subcommittee on Oversight and Investigations on
Federal Oversight of High Containment Bio-Laboratories
September 22, 2009

The American Society for Microbiology (ASM) is pleased to testify before the House Energy
and Commerce Committee Subcommittee on Oversight and Investigations hearing on Federal
Oversight of High Containment Biolaboratories.

My name is Ronald Atlas and I am CoChair of the ASM Public and Scientific Affairs Board
Committee on Biodefense and a Past President of the ASM. I am also Professor of Biology at the
University of Louisville. The ASM is the largest single life science Society in the world with a
membership of about 40,000 scientists and health professionals. ASM members are involved in
basic and applied research, clinical laboratory testing and public health activities that are focused
on developing new preventions, therapies and cures for infectious diseases. To meet the
challenges of emerging and reemerging infectious diseases, microbiologists work in laboratories
in which highly pathogenic agents are stored and studied. The ASM is interested in assuring that
such agents are maintained in a manner that is safe for laboratory personnel and the public.

Infectious diseases remain among the most difficult global health challenges accounting for
about one quarter of all deaths. Newly recognized infectious diseases occur almost yearly, as
evidenced by influenza A (HlNl), avian influenza (H5N1), multidrug and extensively drug
resistant agents (MDRTB/XDRTB), and severe acute respiratory syndrome (SARS), just in the
last decade alone. These episodes have public health as well as economic and political
repercussions. It is critical that scientists in the public and private sectors and health
professionals have appropriate facilities and laboratories for the development of new therapies,
diagnostics, and prevention and detection methods aimed at reducing the risk of infectious
diseases. For example, it is essential that investigators in industry and academia have the proper
facilities to work on these infectious agents to develop new vaccines and drugs for which in
some cases there are few to no existing therapies. Today 30-40 percent of XDRTB strains are
unbeatable with existing drugs and these strains are becoming more common and widespread.

An HlNl vaccine could not have been rapidly or safely developed without existing research
laboratory infrastructure.

Research on pathogenic microorganisms, which is critical for the health and security of the
public and the nation, must be performed safely. Accordingly, the ASM has consistently
supported responsible regulation, oversight, practices and guidelines that improve biosafety in
laboratories and help to protect laboratory personnel, the safety of the surrounding communities,
and the efficacious performance of the research that leads to the vaccines, therapeutic drugs,
diagnostics, and other measures that are so needed today to protect the public against the plethora
of infectious diseases that occur in the United States and globally.

During the past two years, the ASM has met with and provided recommendations to the Trans
Federal Task Force on Biosafety and Biocontainment Oversight and the Executive Order Work
Group on Strengthening the Biosecurity of the United States. We understand that these groups
have undertaken extensive consultation with the public health and research community and that
they will soon release reports and recommendations regarding biosafety and biosecurity. We
recommend careful consideration of their recommendations, as well as a thoughtful and
deliberate approach to any additional or new requirements for biosafety and biosecurity in
laboratories. It took a number of years and substantial effort to arrive at the careful equilibrium
that currently exists to oversee and manage research activities. We believe that precipitous,
excessive policy changes could upset this delicate balance and, therefore, should be considered
in the context of the critical need to conduct public health activities, clinical diagnostic testing
and research on pathogens that will lead to new and improved vaccines, therapeutics, diagnostics
and other measures to protect against infectious diseases, whether naturally occurring or the
result of an intentional act.

The ASM would like to comment on 1) the need for biocontainment laboratories, 2) the select
agent regulations, 3) the importance of biosafety for laboratories and laboratory personnel and 4)
recommendations to improve biosafety. A number of our recommendations continue to reflect
those we made to the Subcommittee in 2007 and subsequently to the federal agency groups
addressing biosafety, biocontainment and biosecurity.

1) The Need for Biocontainment Laboratories High containment laboratories should be
constructed and maintained to ensure the safety of the laboratory workers and the broader
community. Newly emerging and reemerging infectious diseases are appearing at the same time
that microbial resistance to standard therapeutics is on the increase. This lethal combination of
events presents enormous challenges to public health. In an age of extensive international air
travel and commerce, infectious diseases have become a security issue for every nation on the
globe, including the United States. Despite the best efforts of goverrunent agencies, the public
may be at risk for exposure not only to infectious diseases arising within the United States but
also at risk to infectious diseases outside our borders.

Over the past thirty years, public health agencies have confronted a myriad of infectious
diseases, such as pandemic influenza, HIV/AIDS, extensively drug resistant tuberculosis (XDR
TB), SARS, tnelhicillin resistant Staphylococcus aureus (MRSA) Ebola hemorrhagic fever,

Lyme disease, toxic shock syndrome. Legionnaires’ disease, hantavirus pulmonary syndrome.
West Nile fever, and others. According to the CDC, 75 percent of these emerging and
reemerging infectious diseases, including SARS, hantavirus pulmonary syndrome, Nipah virus
encephalitis, influenza, and West Nile fever, are zoonotic, which means that they are transmitted
from animals to humans. Although terrible to contemplate, we must also confront the possibility
of misuse of science. As the scientific community responds to emerging, reemerging, and drug
resistant diseases, it also must prepare to deal with the possibility of an intentional misuse of
science for the creation, or spread, of infectious diseases.

Public health and safety depends upon skilled and highly trained microbiologists and other
health professionals to make every effort to find methods to prevent, diagnose, and treat
infectious diseases and to respond rapidly to emerging and reemerging diseases and threat of
bioterrorism. To meet these challenges, scientists and public health professionals must have
laboratories in which pathogens may be stored and studied in a manner that is safe for
microbiologists and to the community-at-large.

Congress recognized the seriousness of the threat of bioterrorism in the aftennath of the 2001
anthrax crime and increased appropriations for biodefense research. In early 2002, the National
Institute of Allergy and Infectious Diseases (NIAID) convened a panel of experts, the Blue
Ribbon Panel on Bioterrorism and its Implications for Biomedical Research. This Panel provided
guidance on the future biodefense and emerging diseases research agenda, research resources,
facilities and scientific personnel. The capacity of existing biocontaimnent facilities were
determined to be inadequate to meet needs for biodefense and emerging diseases work. New
facilities at BSL 3 and 4 levels of containment needed to be constructed .so that the necessary
research to protect the nation could be conducted safely and to provide surge diagnostic capacity
in the event of a biotenrorism attack or a pandemic disease outbreak. The NIAID has funded 2
National Biocontainment Laboratories and 13 Regional Bioconlainmcnt Laboratories to provide
safe and secure space for biodefense and emerging diseases research. These laboratories help
support the network of 10 nationwide muUidisciplinary Regional Centers for Excellence for
Biodefense and Emerging Infectious Diseases Research that Ihe NIAID has established to meet
the growing challenge of infectious diseases and to combat the threat of bioterrorism.

The establishment of new biocontainment laboratories has been done openly and under the
scrutiny of local municipalities and a federal regulatory and oversight system. They have been
constructed in accordance with environmental impact assessments and other applicable standards
for biosafety. The new BSL3 and BSL4 laboratories constructed with funds provided in part by

the National Institutes of Health (NIH) have been subject to rigorous oversight by NM'NIAID
program staff throughout all phases of design and construction. They are a critical resource in the
nation’s response to the public health issues posed by emerging and reemerging infectious
diseases.

2) Select Agent Regulations The select agent regulations already provide mandatory oversight
of biosafety and biosecurity for laboratories working with these agents, including all private as
well as public laboratories. These laboratories are subject to federal laws, regulations and
policies which seek to ensure a safe and secure environment in which to conduct research on
dangerous pathogens and toxins. They must follow biosafety procedures to protect personnel
working in the laboratory and the outside community. The select agent regulations specify
reporting requirements for any significant problems, violations, or any research related accidents
and illnesses. Institutions are also required to comply with the CDC and US Department of
Agriculture APHIS Select Agent regulations if they possess, use, or transfer select agents and
toxins that have been determined to have the potential to pose a severe threat to public health and
safety. These regulations mandate an FBI security risk assessment for individuals authorized to
have access to select agents, incident response plans, and a security and safety plan to safeguard
the select agents (42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121). The ASM recommends
regular review of the select agent regulations. This review should involve the broad scientific
community. As needed the lists of agents and the requirements of the regulations should be
modified to ensure appropriate biosecurity and biosafety.

The ASM has consistently supported the leadership role of the Department of Health and Human
Services (HHS), the Centers for Disease Control and Prevention (CDC) and the US Department
of Agriculture Animal Plant Health Inspection Service (APHIS) in administering the select agent
and toxin regulations for facilities that possess, use or transfer select agents and toxins. The
HHS, CDC and APHIS are experienced and knowledgeable about infectious diseases involving
select agents and toxins. The HHS, CDC and APHIS are committed to the protection of public
health and safety. We recommend that any changes needed to improve biosafety and to ensure
biosecurify in laboratories build upon existing HHS and USDA programs, including the Select
Agent program, rather than through new statutoiy programs. We continue to support locating the
Select Agent Program at the HHS/CDC for human and overlap agents and at the USDA/APHIS
for animal and plant pathogens because these agencies have the appropriate public health
expertise, laboratory experience in the life sciences and oversight capacity for biosafety and
biosecurity.

3) The Importance of Biosafety Requirements for Microbiology Laboratories and
Personnel The Biosafety in Microbiological and Biomedical Laboratories (BMBL) must set the
standards for the safe handling of infectious agents in the laboratoiy and best practices to ensure

biosafety. Laboratories with capacity at BSL3 and BSL4 are designed to maximize the safety of
laboratory staff and minimize the potential that a pathogen could escape.

There is already extensive government guidance, oversight and regulation of activities involving
microbes and toxins. The Biosafety in Microbiological and Biomedical Laboratories, BMBL,

5th Edition, published by the CDC and NIH, describes microbiological practices, laboratory
facilities and safety equipment for work with infectious agents. Through the BMBL, CDC and
NIH have set standard procedures to be followed when working with infectious agents. There are
also additional guidelines that come from other documents. The shipment of infectious agents is
regulated by the DOT, Department of Commerce, CDC and USDA. Bloodbome pathogens are
regulated by OSHA. The NIH Guidelines for Research Involving Recombinant DNA Molecules
establish safety guidelines for research with recombinant DNA,including recombinant DNA
research with infectious agents. They require institutions receiving NIH funding to have
Biosafety Officers and Institutional Biosafety Committees (IBCs). The NIH Office of
Biotechnology Activities provides resources and training on the role and responsibilities of IBCs,
which examine research protocols, expertise, potential hazards and containment plans. Many
institutions assign IBCs broader responsibility for overseeing research with nonrecombinant
infectious agents.

4) Recommendations to Improve the BMBL, Lists of pathogens, Training, Oversight,
Inventory, International exchange. Transportation, Resources, Reporting and
Accreditation Although there are procedures in place for providing biosafety if properly
followed, there is an ongoing need to review and enhance biosafety. In this regard, there is a
need to ensure adequate training and strict compliance to provide the levels of protection
engendered in those procedures. Laboratory workers who handle infectious pathogens are at
potential risk of acquiring an infection. Therefore, adequate training in microbiological practices
and biosafety is essential to working safely with hazardous biological agents, and protecting the
public health. Exposure and risk may be prevented or minimized by rigorous implementation of
appropriate laboratory practices and containment, safety equipment, improvement and
maintenance of facilities, and formal, validated training of technical, support and administrative
personnel. Laboratory risk assessment is very important because it enables the selection of the
appropriate microbiological practices, safety equipment and facility safeguards for research and
testing.

With these considerations in mind, ASM makes the following recommendations:

Biosafety in Microbiological and Biomedical Laboratories Manual (BMBL: The BMBL
should be subject to regular biennial review and update as needed. More guidance is needed on
specific competencies for biosafety training and recommended procedures for incident reporting.

The CDC, NIH and USDA should take the lead for BMBL revisions and for maintaining the
currency of the list of organisms requiring containment. There should be a broad advisory
committee that includes representation from the relevant scientific and biosafety organizations.
The BMBL should be published in hard copy and made widely available, with aggressive
communication to all involved parties for use as a reference for biosafety. It is important to
establish the rules for biosafety and then accumulate suggestions for modifications based on
experience and evolving scientific knowledge. Compliance with the BMBL biosafety and
biosecurity standards should be a term of award by all federal agencies and there should be
assurance that institutions are adhering to the BMBL.

Lists of Pathogens: Lists of pathogens designated as select agents and those requiring BSL 3
and 4 containment should be regularly updated. The CDC, NIH and USDA should review and
update the BMBL list of agents biennially as is required and more often as needed. A scientific
advisory committee to help guide which organisms are included should be established. There is
also need to harmonize internationally the appropriate levels of containment for pathogenic
microorganisms.

Training; There should be mandatory, periodic training for all personnel working in BSL3 and
BSL4 laboratories. Learning competencies should be established for biosafety training and
formal training programs should be required and documented. The training that laboratory
personnel receive should be validated to ensure the adequacy of biosafety knowledge. Not only
should laboratoiy personnel be properly trained, but also those who are responsible for facility
operations, equipment and management should receive appropriate training. This training is
needed to ensure that all personnel in laboratories where w'ork with biohazardous are competence
to work at a level that provides for their own safety and that of the community.

The NIH Regional Centers of Excellence serve an important role for training and exchange of
information about biosafety practices. Their role should be encouraged and enhanced. As these
Centers develop it will be important to learn from experience, share information, and implement
improved procedures to protect the safety of workers and the wider community.

Oversight; There should be mandated training and performance requirements for biosafety
personnel overseeing the safety of high containment laboratories. The NIH and CDC should
make educational and training programs available. Oversight of biosafety at multiple levels is
essential. Harmonized integrated systems of oversight of all pathogens are needed. Institutional
Biosafety Committees, Biosafety Officers and Laboratory Directors, which evaluate risk and
safety issues at the local level, as well as the institutionally designated Select Agent Responsible
Officials, should ensure instimtional adherence to the BMBL, the NIH Guidelines, and other
applicable regulations for laboratory safety and security.

The CDC and NIH should ensure that good communication channels are in place for biosafety
persoimel to assist them in making informed decisions about risk management. The NIH and the
CDC should consider further guidance and outreach activities for biosafety persoimel to assist
them in regulatory interpretation and containment for research on highly infectious agents and
new scientific techniques, where guidance and uniformity of risk information may not be well
established. Biosafety personnel should work closely with researchers in containment settings to
review and improve safety procedures that protect public health. The occupational health clinic
(or other medical oversight) is also an important part of open communications between those
laboratory workers and the biosafety officers.

The NIH should ensure that biosafety personnel have a clear understanding of the circumstances
for consulting with the NIH Office of Biotechnology Activities on research containment and
regulatory issues. The BMBL and the NIH Guidelines are essential reference documents for
biosafety practice and oversight and should be required for institutions conducting research. The
CDC and NIH should work with research institutions, and the scientific and biosafety
communities to ensure that current biosafety guidelines, regulations for biosafety and biosecurity
are well understood, appropriate and implemented to ensure safe laboratory procedures.
Understanding and adhering to biosafety principles and practices, risk assessment, appropriate
containment and facility safeguards will contribute to safe laboratories, research and testing.

Inventory: The select agent regulations should be revised to change the requirements for
inventory of vials of select agents. Given the intrinsic biological properties of microbes, the
actual counting of vials is meaningless, ineffective, misleading and should not be required.

Rather laboratories should be accountable for which agents they possess and where these agents
are located.

International Exchange; The NIH requirements that foreign institutions must have comparable
facilities and standards to their US collaborators should be changed to remove hurdles for
international collaboration. The current requirements are impeding collaborative research on
infectious diseases and making it difficult to share reagents, antigens and to exchange biological
samples and specimens. Many of the agents of concern only produce disease outside the United
States and studies involving them require that we have a robust and fruitful scientific exchange
with international colleagues. It is critical to maintain collaboration with foreign researchers on
science and public health, particularly on infectious diseases where extensive work is done
internationally. It is vital to ensure the open flow' of biological samples into the United States and
the shipment of samples abroad.

Transportation: A single web site with up to date information on how infectious agents should
be transported should be created. Distribution of microorganisms for identification, research,
reference production, and diagnostic purposes is essential to public health and scientific progress.
Safe handling that minimizes risk is essential. Effective communication from regulators such at
DOT, Department of Commerce, and USDA will aid compliance with regulations.

Resources; The Congress should enhance funding, as needed, to ensure the upkeep of high
containment laboratories are met and that there are adequate funds for biosafety needs, including
personnel training. Biocontainment laboratories are expensive and a large investment, not only in
the cost of construction, but in the cost of operations, maintenance, training, oversight and
community relations. The design and building of biocontainment facilities requires careful
guidance from funding agencies, the development of useful standards for biosafety experts and
managers to ensure effective biosafety, oversight and inspection over the life-cycle of the
laboratory. Facilities must ensure that maintenance and renovations do not result in breeches of
containment.

The needs for additional support for biosafety oversight and maintenance of biocontainment
laboratories should be evaluated to ensure there is adequate institutional, agency and community
support. It is important that the investments made to date by the government in these laboratories
be sustained to ensure their continued safe operation.

Reporting; An improved surveillance and reporting of laboratory acquired illness and response
should be established, even for those incidents not covered by the Select Agent regulations.

There should be a reporting requirement for illnesses suspected of being laboratory acquired.
Incidents of laboratory acquired infections have been documented in the United States.

Notifiable infectious diseases must now be reported to local and/or state public health agencies to
enable assessment of risk and response and to alert physicians and the public to take appropriate
steps, if necessary. However, data on whether the infection occurred in a laboratory is not
routinely collected for many reportable diseases. CDC and Jocal/state public health authorities
should w'ork with institutions, investigators and biosafety personnel to analyze occurrences of
laboratory acquired illnesses and to provide reports and information in a way that will help
reduce the risk and reoccurrence of any incidents. Improved reporting of laboratory acquired
illness, investigation and response would provide valuable lessons for maintaining safe
conditions in research and clinical laboratories. To prioritize interventions and to determine the
effectiveness of those inventions.

Accreditation: Accreditation of high containment laboratories may be desirable and the costs
and benefits should be carefully explored. Any accreditation of laboratories should be well
defined and standards would need to be established before such a program is undertaken. The

select agent regulations already require facilities to be registered, to undergo a safety and
security risk assessment, to clear personnel with access to select agents and to be inspected. The
scientific community is greatly concerned about issues surrounding laboratory accreditation and
should be fully engaged and consulted during federal decision making on standards, guidelines,
and the process for any accreditation program. A formal assessment should be undertaken to
evaluate the costs, benefits and efficacy of registering and/or accrediting high containment
laboratories. The study should address; which high containment laboratories, if any, should be
registered and or accredited; who should be responsible for registration and or accreditation and
what should be the budgetary considerations and how costs associated with accreditation should
be covered.

In conclusion, the laboratory infrastructure in the United States has made tremendous strides in
the past decade to meet the challenges of emerging diseases and biothreats. This progress is
based on the careful balance of research needs and regulatory oversight. Any changes to the
current system should be carefully considered and crafted to ensure this delicate balance is not
upset and impedes research and countermeasures development. These changes should also be
considered with input from the scientific and public health community. We should take steps to
enhance biosafety and assure biosecurity of high containment laboratories by increasing
awareness within the scientific community, improving federal government guidance, establishing
standards for biosafety and, carefully evaluating moving toward a defined accreditation system.
To enhance biosafety we need to build on the culture of responsibility across the scientific
community and enhance a culture that embraces the premise that the misuse of science is
absolutely wrong and that good laboratory practices should be required. Awareness and
education are the most critical components. The ASM would be pleased to work with Congress
and the oversight agencies to accomplish these tasks.

Mr. Stupak. Thank you both for your testimony.

One of the things we have learned from the oversight hearings
is that there is no Federal agency in charge of the expansion of the
high-containment labs. I think the average citizen would be sur-
prised to learn that the government doesn’t even know how many
BSL-3 labs there are in the United States.

On Table 3 from the GAO report — you might want to put it up
on the monitor — we see that the number of BSL-4 labs has in-
creased even since 2007 when we held our first hearing. There are
now two more BLS-4 labs that are fully operational in the United
States since our 2007 hearing. There are also seven more BSL-4
labs currently under construction.

So if we go back and we look at your Figure 1 in the GAO report
and Figure 1 on our monitor, we can see locations of the BSL-4
labs are being built right now across the United States. When
these labs become operational, we will have double the BSL-4 ca-
pacity in the United States without any Federal agency analyzing
whether this is appropriate needs for our country.

And if we look at Figure 2 in the GAO report, we can see that
the number of BSL-3 labs has continued to increase in the same
period of time. Table 4 shows there are about 1,400 BSL-3 labs in
the United States, and these are only the BSL-3 labs registered
with the Federal Government. We can only guess how many there
are out there, because they don’t have to register unless it is han-
dling one of those agents.

Do you have any concerns about the increase we have seen in the
number of high-containment labs?

Ms. Kingsbury. Yes, sir.

Mr. Stupak. Could you explain your concerns.

Ms. Kingsbury. Well, the concern is, there may be a need for
this number of laboratories, but nobody is looking at the total pic-
ture. Nobody is looking at what the public health and public safety
research needs are, and linking that to where labs are built and
how many of them we need. And if you look at the combination of
Table 4 and Table 5, which are the labs that are registered with
APHIS at the Department of Agriculture, you end up with more
than 1,600 BSL-3 labs out there. That just seems like a lot.

Mr. Stupak. You mentioned the Department of Agriculture, and
Dr. Atlas, in your report and letter that you sent after our last
hearing — were you the author of that letter or was there a team
that did that?

Mr. Atlas. We have a team.

Mr. Stupak. — you mention about — because of APHIS and the De-
partment of Ag there, because 75 percent of the new infectious dis-
ease we are seeing actually comes from animals passed to humans;
is that correct?

Mr. Atlas. That is correct.

Mr. Stupak. Dr. Atlas, do you have any concerns about this in-
creased number of labs we are seeing?

Mr. Atlas. I don’t think I have the same sort of concern that is
expressed in the GAO report because I see these labs as safe labs.
If you tell me that we are creating more safe infrastructure within
the Nation, where research can be performed, that is something
that I support.

So from that sense, no, I don’t have the same concern in terms
of safety when you tell me it is a safer laboratory structure.

Now, is it more safe than we need? I guess I don’t see things that
way.

Mr. Stupak. Let me ask you this question. In your October 4th
letter, and it was updated in July of this year for this hearing, on
the second page it says, “Facilities at BSL-3 and -4 levels of con-
tainment have been constructed because the number and capacity
of existing biocontainment facilities were determined to be inad-
equate to meet the needs for biodefense and emerging disease
work.”

What is the right number then? What is the right number we
need of Level 3 and Level 4 labs?

Mr. Atlas. I don’t know the right number overall. Certainly
there was an assessment done at the National Institutes of Health
that suggested we needed something on the order of 10 to 15 re-
gional laboratories to cover the Nation that would provide core re-
sources for the research and potential surge capacity if we had a
major outbreak.

Beyond that, a number of institutions have seen the need or de-
sirability to have small laboratories where they could do research
on agents in a safe manner.

Mr. Stupak. My concern is — and I think Dr. Kingsbury pointed
out — unlike, let’s say, nuclear material, with these agents, they are
always growing, expanding. And in looking at the GAO report, and
even your report or your testimony, one of these errors we have is
human error and it just comes inherent with the job. And with nu-
clear, we try to contain it, we try to have less people handling it,
less chance of error.

Doesn’t the same logic hold true here that the more labs you
have, the more scientists and researchers you have handling this,
the more likely a disaster, not just within the lab, but escaping out-
side the labs?

Mr. Atlas. Not if we have the appropriate safety standards, and
I think that is where we would put our emphasis on increasing the
training and the resources to ensure that all of the workers in the
laboratory are performing safely. I think it is important

Mr. Stupak. But there really is no safety. It is on-the-job train-
ing, isn’t it? If I am a researcher, it is basically — I don’t go to some
school to learn how to do it.

Mr. Atlas. There are safety courses that are offered.

Mr. Stupak. But not required.

Mr. Atlas. They are not required, and therefore you are correct
that much of the training is on the job.

I think what the ASM would propose is that we, in fact, move
to a system with national standards that would establish minimum
guidelines for the training and that we provide the resources where
we can assure this committee that anyone who is walking into a
laboratory where dangerous agents are contained is adequately
trained; and further, that we instill in the community a culture of
responsibility with a zero tolerance for not following the proce-
dures.

Mr. Stupak. Sure.

Let me ask you this. If you go back to Figure No. 3 that we had
up — it is in the GAO report.

It is Figure No. 2 where you went from about 400 BSL labs in
2004 to almost 1,400 in 2008. Can you find that chart?

The question I want to ask — that is 2004, and we go up to almost
1,400. Were these labs always in existence, and they never re-
ported the select agents they are dealing with? I mean, how

Mr. Atlas. That is probably true. What this graph represents is
the number of laboratories, I believe, registered for work with se-
lect agents. It does not necessarily represent the construction of
new laboratories.

Mr. Stupak. No; I know that. If I have a university, I may have
many labs within my university structure.

If you are supposed to be registered before, is there that much
more interest in these 80 select agents; or have they always been
doing the work, and we never knew about it? Which once again
shows no coordination or no one is in charge here.

Mr. Atlas. In post-2002, the Nation has made a significant in-
vestment in bioterrorist-related or potentially related organisms.
That has brought a great deal — as pointed out, we went from a
very small budget to a $1.7 billion sort of investment in research
that was largely in the research to be conducted rather than con-
struction of new laboratories. And that has led to a number of indi-
viduals joining in the effort to develop vaccines against Ebola and
anthrax and the other diseases, to protect the Nation about what
is now seen as a new threat from the misuse of biological weapons.

Mr. Stupak. It is sort of like what Mr. Walden said: We put the
money out there and suddenly everyone became BSL-3 labs that
do research. They follow the money and not necessarily the threat?

Mr. Walden. I didn’t say that.

Mr. Stupak. I know you didn’t say that. I’m summarizing.

It almost seems like if we throw money out there, suddenly we
are all BSL-3 and BSL-4 labs.

Mr. Atlas. Certainly, when I testified before the Congress in the
2002 era, there was a perception that we had a tremendous threat
facing us, and we had to combat that threat by racing to develop
stockpiles of vaccines and therapeutics that could be moved across
the Nation.

We needed better vaccines; when we looked at some of the ones
we had, we decided they weren’t safe enough. Smallpox vaccine
that you and I once used, we weren’t going to give to our children;
we wanted something safer than that.

We called upon the National Institute of Allergy and Infectious
Disease to move forward with that. And, in fact, it has been a tre-
mendous investment, that has been brought forth with congres-
sional support and fervor, because the Congress was very worried
about this disease. The community has responded by trying to per-
form the needed research, and that has led to an expansion.

Mr. Stupak. Mr. Walden.

Mr. Walden. Thank you, Mr. Chairman.

I have the dubious honor of representing the area with the larg-
est biological attack on U.S. soil. The Bhagwan Shree Rajneesh set
up encampment in southern Wasco County outside the town of An-
telope. They concocted a little mixture that they then spread in the

salad bars in the city and poisoned hundreds of people. It took the
Federal Government more than a year to admit that it was actu-
ally a biological attack, this Salmonella strain that they spread.

So I take this issue real seriously and realize there is a threat
that if the folks in that encampment could pull it off, it could hap-
pen by a serious terrorist somewhere.

Do you think there is still a pretty good threat against the coun-
try?

Mr. Atlas. We understand that there is a threat of criminal ac-
tivity and terrorism and that we need to be vigilant.

From the community’s perspective, we need to develop a true
taboo against the use of biological weapons. It is a zero tolerance —
nowhere, no-how, no one — which also suggests that the community
must be your eyes and ears and that we need a system whereby
the community can responsibly report any suspicious activities that
might represent misuse, and that the community has zero toler-
ance for a lack of adherence to biosafety procedures.

Mr. Walden. So, Dr. Atlas, I think that is a very salient point.

Is there such a system in place where scientists who observe
something they believe to be inappropriate can effectively commu-
nicate that to somebody who can do something about it, at least
check?

Mr. Atlas. I don’t think we have an adequate coordinated sys-
tem of knowing who to call, other than your local FBI office, which
may not have the ability to adequately understand the information.

Certainly, the American Society for Microbiology has put forth
and is putting forth every day to our members a code of ethics that
calls upon them to only use the science for the betterment of hu-
mankind and to report to appropriate authorities any potential
misuse of the science.

Mr. Walden. Dr. Kingsbury, I haven’t had a chance to thor-
oughly go through your report, but did you look at those issues at
the GAO?

Ms. Kingsbury. The issues you are talking about, the outbreak
in Oregon?

Mr. Walden. No. I am sorry. I moved off that into what Dr.
Atlas is suggesting, that there isn’t a really good reporting mecha-
nism for scientists to feed in observances of misuse of some of these
agents.

Ms. Kingsbury. There is really not, in any of the programs that
we see.

Mr. Walden. Did you review that in the course of your investiga-
tion, though, that issue?

Mr. Sharma. We looked at it in context of the Department of De-
fense and the Department of Energy, which do have a personnel re-
liability program. Even in those highly intrusive programs, there is
no mechanism whereby a coworker can report on his coworker.

Mr. Walden. Do you make recommendations in your report
about such a system?

Mr. Sharma. We made a recommendation that the Secretary of
HHS and Agriculture — if they decide to implement this as a way
to mitigate the inside risk, that they should consider the cost and
impact of this program.

Now, let me just say within the Department of Defense we talked
to a number of scientists who are working in BSL-3 and BSL-4
labs and they all unanimously said that a determined scientist, de-
spite the intrusive nature of the PR people, as they are called, can
easily take the material out. There is nothing there that can stop
a determined scientist.

Mr. Walden. So, in other words, there is nothing we can do to
stop a mad scientist from taking the pathogens out and doing
whatever they want to do with them.

Ms. Kingsbury. We already have laws against doing what some
people might do to harm people.

Mr. Walden. Is there a way to do some presecurity clearance?
I don’t want to bog down our whole research system.

Ms. Kingsbury. That is what a personnel — a more stringent per-
sonnel security program would probably require. There is a cost to
that. And the whole basis for our concern about the growth in the
number of laboratories is grounded in the fact that this Federal
Government needs to make some hard choices about costs.

So you can’t do that if you are not doing an evaluation of what
things cost and what you are getting from them.

Mr. Walden. And what the risk is.

Ms. Kingsbury. What the risk is, exactly right.

Mr. Walden. We have heard these four incidents and then the
latest, which was actually the Level 2 lab. How many are there?

If you had 1,600 labs — by the way, that doesn’t mean 1,600 sepa-
rate buildings; is that right? As the chairman said, you have got
multiple labs that are in the same center.

Ms. Kingsbury. Can be, but nobody knows how many there are.

Mr. Walden. Does each agency that has labs know how many
labs that they have? Does HHS know how many labs they have?
Does USDA know how many labs they have?

Ms. Kingsbury. The Federal agencies probably do, yes.

Mr. Walden. So somebody knows, silo by silo, agency by agency,
what labs they have?

Ms. Kingsbury. Which ones have been built by the Federal Gov-
ernment. But these labs are being built by the State government,
they are being built in the private sector, they are being built by
other than the Federal

Mr. Walden. If I wanted to go out and build a lab and deal with
these agents at Level 3 or 4, can I do that and not tell anybody?

Ms. Kingsbury. You can’t do it and not tell anybody if they are
on the select agent list.

If they are not on the select agent list, then, yes, you can. All
you have to do is get the money for it.

Mr. Walden. And the select agent list is the one that has the
worst of the worst?

Ms. Kingsbury. Most of the worst of the worst.

Mr. Walden. So that raises the issue, should other agents be
put — who gathers up the select agent list?

Ms. Kingsbury. CDC and the Department of Agriculture, sepa-
rately for human pathogens and plant and animal pathogens.

Mr. Walden. All right. You said you thought there were too
many labs at 1,600.

Ms. Kingsbury. We said we don’t know whether there are too
many, whether there are too few.

Mr. Walden. I thought you said earlier today that you thought
there were too many.

Ms. Kingsbury. I very carefully said, we need to find out how
many are really out there, we need to look at the national strategy,
the current consideration of the biothreat and decide whether that
amount of capacity is less than we need, the same of what we
need — and so we have got it right by guess — or more than what we
need.

And if I were a betting person, my bet would be on more.

Mr. Walden. We have more labs than we need?

Ms. Kingsbury. There is a very, very large capacity to do this
kind of work, and without looking again at the threat, without
looking again at how much we really need, in comparison, at least
at the Federal level, to the other needs facing our Nation today, I
think that is a very important analysis that should be done.

Mr. Walden. But you haven’t done that analysis, so that would
be a personal opinion?

Ms. Kingsbury. It is our view that the analysis should be done.
It would not be appropriate for GAO to do it. GAO would argue
that the executive branch has the responsibility for doing that.

Mr. Walden. And would it be helpful — I assume when these
other reports come out or are finalized by the Obama administra-
tion that you all will take a look at those before going forward.

Ms. Kingsbury. We will be very interested in looking at them in
the context of some of our other ongoing work. Or if this sub-
committee would like to ask us to do that, we can do that as well.

Mr. Walden. Wouldn’t that round out your report?

Ms. Kingsbury. It might.

Mr. Walden. Thank you. My time has expired.

Mr. Stupak. Mr. Green for questions.

Mr. Green. Thank you, Mr. Chairman.

You and the ranking member asked some of the best questions.
And why don’t we have some type of mandatory certification,
whether it is filled by State government or private entity.

Dr. Atlas, is there any reason you can think of of not having
some registration between these Federal agencies that oversee it?

Mr. Atlas. I think the only issue from the community is the
question of overregulation. A registration per se without require-
ments for performance doesn’t get you very far. When you begin to
impose inspections and other performance requirements, the ques-
tion is, are they really helping you in terms of improving safety or
security or are they paperwork.

Mr. Green. When you are talking about BSL-3 or BSL-4 lab
regulation and inspected on an annual basis, it doesn’t seem like —
and some standards, I would hope, whether they are State-owned
or privately owned, they would have their own safety standards, it
would be common between these companies and State governments
or even the Federal government.

Mr. Atlas. For the most part, I think that is true, and certainly
when we are dealing with the select agents, there are regular and
sometimes multiple inspections by different agencies.

And for those labs, going back to the earlier question, the govern-
ment knows exactly where they are, they know which agents are
there, they know their performance requirements, and they have
copies of all of their manuals of operating procedures.

It is the other naturally recurring agents, whether it be the cur-
rent influenza virus that is circulating or SARS when it broke out,
that that was put into a laboratory, where we are not seeing the
same oversight that we see for the select agents.

Mr. Green. And I agree with you we don’t want to stop the re-
search because I agree with HlNl, that we couldn’t be on where
we are at now in the development without lots of different folks
looking at it and different not only government agencies but non-
government. But it just seems like between the Department of Ag-
riculture and NIH or FDA we could have a Memorandum of Under-
standing so they would have the same standards and they would
split up the requirements, that they would have common standards
to the benefit of the labs.

Mr. Atlas. To some extent there is certainly coordination be-
tween agriculture and HHS on many of these issues. I think what
the ASM has proposed is that we have a full study of cost and ben-
efit of moving towards standards, figure out what those standards
would be and then see whether or not it is appropriate to institute
an accreditation system across all the high containment labs. We
are not ready to sort of jump off the bridge and say “mandate that”
until we understand the cost benefits and what we would be look-
ing at, but we think that that sort of study and examination ought
to be done and done now.

We have made that recommendation before both the Executive
Order Working Group and the Trans Federal Task Force. I don’t
know whether or not that has been accepted and whether that will
move forward.

Mr. Green. Dr. Kingsbury, in your testimony you talked about
the decreasing budgets particularly for the agencies. And yet with
a proliferation of the number of BSL3 labs, the doubling the BSL4,
and nearly increase of 1,400, are we not seeing these agencies re-
spond because they don’t have the funds to develop this coordi-
nated effort?

Ms. Kingsbury. That is part of the issue I suspect. It is also be-
hind our concern about if you are going to have this many labora-
tories you really need to think ahead about how you are going to
fund them from a maintenance perspective. So it is all tied up in
the same thing. I think what agency officials that we met with told
us about this issue of interagency coordination is no one agency
currently believes that it has the authority to direct another agency
to do anything about the labs it funds. And so each agency may
know what they have, but nobody, and one of the reasons we di-
rected some of our recommendations to the National Security
Council and the National Intelligence Council is that it would take
something at that level, at the White House level, to figure out
what needs to be done to give a single entity sufficient authority
to do the kinds of things we are talking about here.

Mr. Green. So you don’t think you would need legislation, it
could actually be done under current regulations?

Ms. Kingsbury. I am not sure whether we need legislation or not
frankly. I am looking forward to these reports that we have been
talking about because we have some expectation that that issue
maybe taken up.

Mr. Green. Thank you, Mr. Chairman. I am all out of time.

Mr. Stupak. Mr. Gingrey, questions, please.

Mr. Gingrey. Mr. Chairman, thank you and, Mr. Chairman, I
apologize to our witnesses. Dr. Kingsbury and Dr. Atlas, for being
late. I had a press conference, but I am glad I didn’t miss this. I
know it is a very important hearing, Mr. Chairman, and I appre-
ciate your holding it.

Dr. Atlas, let me ask you this. You reference the need for careful
consideration of recommendations regarding new requirements for
biosafety and biosecurity in laboratories in light of the very careful
equilibrium that currently exists to oversee and manage research
activities, and you also state that excessive policy changes could
upset the delicate balance.

Dr. Atlas, what could be the impact on our scientific community
if we were to pursue a policy, certain changes that did upset that
delicate balance, what would be the consequences of that?

Mr. Atlas. The consequence is that the Nation would be less
safe. If we don’t carry out the research that we need on infectious
disease, if we have scientists abandoning work on pathogens to
work in other areas, then, in fact, we are not going to have the vac-
cines we need. We are not going to have the therapeutic drugs, and
we are going to see that we cannot contain outbreaks of disease.
If you went to an extreme, you just wouldn’t have a vaccine for
HlNl coming in a few weeks.

So we need to ensure that we are not having a burden on the
community that causes scientists to say, I am going to go work
elsewhere. That is the call for careful evaluation. It is not a call
for no regulation, no oversight. Quite the opposite. It is a call for
carefully considered, appropriate regulation and oversight. What
one doesn’t want is a knee-jerk reaction that says, oh, my God, we
have to do something, let’s do it today without thinking through
the consequences, but once you have broad input from the commu-
nity with leadership of HHS and USDA, the ASM thinks we can
move ahead and continuously improving the system and that we
need to have that done on a regular basis. It is not a one-time af-
fair.

Mr. Gingrey. Dr. Atlas, thank you, and I appreciate it. I want
to use my remaining time to also ask Dr. Kingsbury a very impor-
tant question as well. To my knowledge. Dr. Kingsbury, two gov-
ernment reports were recently completed that deal with the subject
of strengthening oversight of biosecurity in the United States, one
completed by the Executive Working Group and, in fact, sent to the
President in July, the other I understand just completed by the
Trans-Federal Task Force on Optimizing Biosafety and Biocontain-
ment Oversight, which is chaired by HHS and USDA, as you know.
Given the subject matter of these yet to be released reports, I am
wondering whether you think this hearing might have been better
served or could be better served with these reports available for us
to consider?

Ms. Kingsbury. “Might” may be a good word, but we don’t sub-
stitute our judgment for the committee chairmen about when they
want to have a hearing.

Mr. Gingrey. I am not really asking you to second guess the
chairman. I am just asking you your opinion in regard to these re-
ports.

Ms. Kingsbury. I am here to report to our work, sir, not my per-
sonal opinions.

Mr. Gingrey. Thank you very much. I will ask Dr. Atlas the
same question in my remaining time.

Mr. Atlas. I think the answer is we would be happy to meet
with your staff or your committee again once those reports are
issued to continue our dialogue.

Ms. Kingsbury. We just talked recently, a few minutes ago,
about the possibility of the chairman asking us to look at those re-
ports and give him our views.

Mr. Gingrey. Certainly. Well, again let me just say I think it is
important that we, Mr. Chairman, maybe I would suggest that you
strongly consider having a hearing, another hearing once those re-
ports are released in light of this hearing today, and with that, Mr.
Chairman, I will yield back my time, and I thank both witnesses
for their response.

Mr. Stupak. Thanks, Mr. Gingrey. Mr. Burgess for questions,
please.

Mr. Burgess. Thank you, Mr. Chairman. I apologize for being
late.

Mr. Chairman, I guess the question may have already been
asked to you and we can discuss this afterwards, I don’t under-
stand why we don’t have someone from the Department of Home-
land Security here on the panel.

Now the Department of Homeland Security recently selected
Kansas as the site for the new foot and mouth disease facility. Are
level 4 labs, and I will ask this to both of our witnesses, are level
4 labs appropriate for inland research diseases such as foot and
mouth disease? Wouldn’t it have been better to hold the hearing
before we held the vote? You don’t have to answer the second part.

But is an inland facility appropriate for this monitoring and re-
search on a very contagious illness? Because 40 percent, 45 percent
of the Nation’s cattle traverse the State of Kansas at some time in
their lives.

Ms. Kingsbury. It was a very large number in a recent resolu-
tion discussion in the House about that. We issued a report re-
cently that looked at the question not asking our opinion per se
about whether it is appropriate to put a facility on the mainland
as opposed to an island, but rather looking at the evidence that the
Department of Homeland Security put forth in making that deci-
sion and concluding, as they clearly did conclude, that there is no
risk of doing foot and mouth disease research on the mainland, or
essentially no risk. Then the facility that is being talked about is
going to do more than foot and mouth disease, but the thing that
has continued to concern us is that. A, foot and mouth disease is
the most infectious virus on the planet, and, B, the research on
that requires research with a lot of very large animals. And so the
whole design and operational structure of that facility on the main-

land where cows are in the neighborhood has not yet heen laid out
in a way that we would conclude, and our experts would conclude,
has demonstrated that it is safe to do foot and mouth disease re-
search in particular in that facility.

Mr. Burgess. When do you expect that we will have the avail-
ahility of that information, or will this just be information that is
gained along the way after the facility opens?

Ms. Kingsbury. Well, the Kansas State University folks and the
people who are putting that facility where they have selected to put
it in the Department of Homeland Security will have to develop a
design for the building, they will have to develop operating proto-
cols, they will have to develop all of the things about how you
would contain an outbreak if it did get out, and so forth. And those
are the things that aren’t developed yet but hopefully would be de-
veloped before any of that virus actually enters the building.

Mr. Burgess. “Hopefully” may be a good word there as well.

Dr. Atlas, do you have anything to add to that.

Mr. Atlas. I think that one can design and operate a BSL4 agri-
cultural facility safely. As to the exact location, the risks, I will
leave that to the DHS and the community. But clearly the Kansas
community wanted that facility there for that, in that location. It
was not a matter of their saying, the Federal Government is put-
ting something where we don’t want it.

It was also clear that Plum Island either needed massive renova-
tion or the facility needed to be relocated to a location where the
scientific community would join in the critical research that is
needed as was pointed out not only on foot and mouth disease but
on many of the other agriculturally relevant agents that would be
worked on there.

So something had to be done to provide an adequate facility, and
my contention is that you can build an adequate facility and locate
it in an appropriate place.

Mr. Burgess. An observation from Galveston a year ago of
course Hurricane Ike ravaged the island as even today had some
difficulty recovering but a brand new biodefense laboratory that at
that point was not occupied but certainly came through what I
would regard as a very serious stress test came through with pret-
ty much flying colors. These labs are expensive to build. They are
expensive to maintain. Is the funding level for both the building
and the maintenance, are those funding levels adequate? Is that
something that is receiving the appropriate amount of scrutiny and
the appropriate amount of monitoring?

Ms. Kingsbury. We didn’t directly look at what the funding level
would be. There is an initial funding being discussed in current ap-
propriations discussion, but what the entire facility will end up
costing I think I would argue we don’t know yet.

Mr. Burgess. What about the maintenance dollars?

Ms. Kingsbury. We are very worried about the maintenance
issue. The outbreak of foot and mouth disease in Great Britain was
directly tieable to a maintenance issue in a relatively older facility.
So as these facilities age, it will be very important to continue to
pay attention to how much maintenance is going to be necessary
and to provide the support for doing that.

Mr. Burgess. And the fact that that has to go through our an-
nual appropriations process makes for some additional uncertainty.

Ms. Kingsbury. In a time of very high budget constraints.

Mr. Burgess. Sure. And again, Mr. Chairman, I think that is
something this committee needs to pay particular attention to as
we go through the next several years because as we have seen from
our appropriators before, and I understand the difference between
an authorizer and an appropriator. If you go up to the NIH, all the
buildings were named for an appropriator, there is none named for
an authorizer. I do understand the difference between an author-
izer and appropriator, but it is certainly our job to keep up the
oversight on that and when, as correctly Dr. Kingsbury pointed out,
as those budgetary dollars are squeezed, we need to make certain
that areas where legitimate functions of government are not com-
promised.

I will yield back the balance of my time. Thank you.

Mr. Stupak. Thank you, Mr. Burgess.

A couple of questions if I may. On page 32 you have table Num-
ber 10 which shows the 12 Federal agencies that have the BSL3
and BSL4 labs, but none of them outside their own agency know
how many labs that really exist BSL3 or BSL4, correct?

Ms. Kingsbury. That is correct.

Mr. Stupak. You indicated in your testimony, how many of these
12 agencies, I think people would be surprised even the Depart-
ment of the Interior has these labs, how many of them have per-
sonnel reliability measurements or protections of the 12 agencies?
The Department of Defense you said, does anybody else?

Ms. Kingsbury. We don’t think so. Do we?

Mr. Sharma. Department of Energy.

Mr. Stupak. Because of nuclear labs?

Mr. Sharma. Within the last year they have begun to implement
a personnel reliability program.

Mr. Stupak. Just last year?

Mr. Sharma. Yes.

Mr. Stupak. So of the 12 agencies, the only robust one would be
Department of Defense, Energy is starting, so we have 10 more
without any kind of measurement. OK.

Dr. Atlas, do you think academic and private institutions, do you
think they should be registered labs level 4 and level 3? Do you
think they should be registered with the government?

Mr. Atlas. And I think the question is what comes with the reg-
istration? If you just mean someone should send you a note that
says we have a laboratory and it doesn’t bring anything else about,
I don’t see much value. But there is also very little burden, so you
are not going to get resistance to that. I think the Census, if you
are going to register the labs you ought to be asking additional
questions, and that is where the devil will be in the details about
what it means to register and potentially be accredited at the end
of the day. So I do see a value in a system that ensures increased
biosafety, that reassures this committee and the public at large
that what is going on in the laboratories is being appropriately
done.

Mr. Stupak. We don’t know what is going on in laboratories un-
less they tell us, right? And if you are one of these select agents.

you are level 3 or you are level 4, so why would there he a reluc-
tance to register with the government the labs?

Mr. Atlas. I think first of all for the select agents, they are reg-
istered. Everybody has to go through a clearance process. The gov-
ernment knows exactly where those laboratories are and every-
thing that is going on in those laboratories. If you talk about lab-
oratories which might be isolating a new and emerging infectious
disease organism, there are questions about how quickly and who
you would tell and what you are doing particularly if you in the
private sector.

Mr. Stupak. Let’s say I am at a level 3 lab and I am not doing
a non-select agency. Shouldn’t I still register with the government?
One of the questions that has been going around here this morning
is how many labs do we need. If we have 2,600 level 3 labs do we
need 2,600?

Mr. Atlas. I think it would go back to the question how many
of these are coming from government funding? That is how much
is the government investing versus someone sees an opportunity to
develop a vaccine, is willing to invest in that vaccine or therapeutic
drug development of which we have a real problem getting people
to invest, but if companies see that and they build a laboratory to
safely perform the work to develop a new vaccine against influenza
virus, they ought to be able to do that I would argue, that that is
part of the entrepreneurship of this country. Now should they have
to do it safely? Absolutely.

Mr. Stupak. Sure, but one of the criticisms has been we have
thrown a lot of money at this issue since 2002. If there is a lot of
BSL3 labs out there that could do the work, why would the govern-
ment build more BSL3 labs because we don’t know if they are
going to exist if we are not registered. I guess that is the part I
am trying to get at.

Mr. Atlas. I am not convinced that the government is spending
a lot on building new laboratories. That was not as I saw it part
of the GAO report was actually the dollars going into the labs. It
was charts that showed an increase in the number of registered
laboratories which may represent academic and private sector as
well as the public sector.

Mr. Stupak. And we don’t know, we don’t know how many there
are. Even you point out in your testimony that the real expense is
not just building but the maintaining because of the high level of
sophistication you need to maintain a level 3 or level 4.

Mr. Atlas. I think going back to the earlier question, that is
where the ASM would also register our concern, is that we have
to be vigilant about ensuring maintenance.

Mr. Stupak. You make a number of recommendations about
seven I heard here today and in the letter you sent in 2007 you
had a number of them, and a lot of them probably would not re-
quire Federal rules or laws such as increased training or reporting
of incidents but has ASM membership, have you taken it upon
yourself to do this without government regulation or government
lead here and reporting incidents and doing training, you men-
tioned training? Why doesn’t the organization do it instead of hav-
ing government mandates?

Mr. Atlas. I think we look to the CDC and NIH to impact, take
the leadership role in guiding the community in this regard. They
are the primary authors along with USDA of the BMBL, and the
ASM is seeking increased input into that process. But in terms of
developing a responsible culture of reporting incidents, that I think
needs to he within a government function.

Mr. Stupak. I am just a little surprised. You are a scientist. I
would think you would want to take the lead here in the develop-
ment without government intervention or telling you how do it.

Mr. Atlas. Where ASM comes from would he working with the
government to in fact see that a system is implemented, not trying
to undermine or circumvent what properly would he a role of public
health.

Mr. Stupak. Mr. Walden.

Mr. Walden. Thank you, Mr. Chairman. Dr. Atlas, I sure appre-
ciate your testimony and comments today. I especially when you
said that you wouldn’t necessarily want the government deciding
somebody couldn’t open the lab to go figure out the new and latest
vaccine, I don’t want a government complete takeover of this whole
process. What I want is to make sure those labs are safe and se-
cure. And I think it makes sense that we kind of know what is out
there, where they are, and I appreciate your testimony too and you
talk about just sending in a note saying I am a lab and I am here
doesn’t really accomplish the goals of safety and security. And so
I appreciate what you have had to say today.

You also had some really I thought good recommendations that
you shared with us and I understand also shared with the Trans-
Federal Task Force and the Executive Working Group.

How were those recommendations received by those two organi-
zations?

Mr. Atlas. Well, we are waiting to see the report which we have
not seen. They certainly had broad input not only from ASM but
many other organizations shared viewpoints with both of those
groups. They held public hearings. We attended those. There was
broad input, and now we, like you, wait for the outcomes of that.

Mr. Walden. And I appreciate that and we look forward to their
response. My understanding is there are 242 entities doing this
type of research that are registered, which then among those enti-
ties constitute the 1,362 laboratories. So in a given university set-
ting we can be sending Federal tax dollars in to do this research
toward HlNl vaccine or toward anthrax vaccine or whatever we
have decided as priorities, that goes into those 242 entities and
within wherever they do their research they are multiple lab,
right?

Mr. Atlas. Yes. And how they decide to define a lab which may
be that the animal facility may be one laboratory and then the
room where you actually do research outside of the animals could
be a second lab. One of the issues pointed out in the GAO report
is that we do not have a standard definition for what constitutes
a laboratory. We do have a definition of what an entity is that has
to report that they have a select agent, but it has to be a contig-
uous property.

Mr. Walden. So let me switch gears for a second. If you were
the National Security Council and you were advising the President,

who would you pick as the lead agency to oversee this national lab
network?

Mr. Atlas. I would see it from a safety perspective and a public
health perspective and in turn to HHS, so the ASM as consistently
sought the leadership of HHS and USDA and not supported in
prior testimony a DHS oversight of that because we have seen it
as a broad public health issue which then does combat pathogens
which potentially are misused, but we are looking at the broad
emergence of infectious diseases.

Mr. Stupak. And that would also bring in CDC and their experts
into that process.

Mr. Atlas. Certainly CDS, NIH within the HHS context is there.
Now ASM did support within the oversight system the involvement
of the Department of Justice and the FBI clearance process for who
could enter select agent labs, it wasn’t just saying put public health
in charge where there are security concerns, but it did say if at the
end of the day we are really concerned with protecting public
health and animal health then the agencies that have experience
in those areas ought to be the lead agencies.

Mr. Walden. Dr. Kingsbury said there are long-term mainte-
nance issues and they are quite concerned about them.

Can you, representing those working in these labs, can you talk
to us briefly, I know I have a minute left, in terms of those mainte-
nance issues that are out there?

Mr. Atlas. What we what we saw in the foot and mouth incident
in England does raise the issue of maintenance, and certainly what
we see in the academic community is you get the money up front
for something and they will let the facilities run down, you never
see them in any university I have been associated with, to have an
adequate maintenance budget. So you keep deferring your mainte-
nance. And in these facilities you can’t afford to do that. There
really does need to be adequacy and oversight of maintenance.

Mr. Walden. Thank you. I appreciate your testimony, both of
you, today. Thank you, Mr. Chairman.

Mr. Stupak. Mr. Gingrey, questions?

Mr. Gingrey. No, Mr. Chairman.

Mr. Stupak. Mr. Burgess, any follow-up?

Mr. Burgess. Yes, Mr. Chairman, if I could just ask a general
question. I guess Dr. Kingsbury, but Dr. Atlas, please feel free to
weigh in as well. With regards to Plum Island, do we have a ball-
park estimate as to what it would cost to do those upgrades that
you alluded to that might be quite costly?

Dr. Kingsbury. First of all, we would have to recognize that
Plum Island has done already spent a lot of money upgrading their
current facility. And when they made an application, if you will, to
be considered in this recent decision process, they identified an-
other part of their island where they could build the kind of facility
that would need to be built to do the broader range of research.
That is relatively costly compared to exactly the same building on
the mainland because all the materials have to be shipped onto the
island. So the DHS has always made that point as one of the rea-
sons that they don’t find the Plum Island solution attractive.

But you could build almost the same kind of building there. It
is just a matter of whether the additional cost is prohibitive. There

have been expressed concerns about recruiting scientists to work on
an island. It is a fairly pleasant 45-niinute ferry trip to get there.
We have done it. It hasn’t seemed to be a big deal with respect to
recruiting enough scientists. That remains to be seen if we were
going to try to do that. But we recognize in our report that Plum
Island has already invested a great deal in upgrading their current
facility and for a 50-year-old building, it is in pretty good shape.

Mr. Burgess. So in a dollar-to-dollar comparison, Plum Island
versus an inland facility the cost is about the same but there are
logistic issues that would make the building easier?

Ms. Kingsbury. It would cost a lot of money.

Mr. Burgess. But there are also security issues that will cost
money at an inland facility that are perhaps not calculated in this
equation?

Ms. Kingsbury. That is correct, and DHS did not take that cost
and those designs into account in making their decision.

Mr. Burgess. Just going back to Mr. Walden’s point for a mo-
ment about the HHS ultimate being the one who has the super-
visory role, does there need to be an entity that oversees HHS on
that because of the security concerns that exist that Mr. Walden
was bringing up? I hesitate to use the word “czar,” but does there
need to be a bio czar that is looking at this from more of a security
standpoint?

Mr. Walden. No more czars.

Ms. Kingsbury. We focused most of our work on the biosafety
side of these issues, not the biosecurity side. Some of our colleagues
testified this morning on a physical security examination that they
did of several of the BSL4 laboratories. The problem there is what
is the actual threat and what is the experience that has happened
over the past years of anybody breaking into a lab, and we are not
aware of any incidents. That would suggest that physical security
upgrades may or may not be needed.

Mr. Burgess. On visiting the new lab in Galveston, I was im-
pressed with the security. Always of course you do have to ask
yourself what is the threat from an internal disruption or an
Earth, someone who is working in the facility that decides to take
a different approach to their employment. So what do we have
available to help us with that?

Ms. Kingsbury. Well, that is what a personnel reliability pro-
gram would help with, but again even in that case there has been
only one alleged case of an insider doing illegal things in the way
that we all worry about. And so I think to study it and to think
about how you are going to invest the taxpayers’ money, looking at
the question from a somewhat broader context really is important,
including how much of this research capacity do we need? We have
built a lot of it as we have been talking about through this whole
hearing there is a lot of young scientists out there getting very in-
terested in these kinds of jobs. What happens if the funding for
supporting that research dries up? Where are those scientists going
to go with the skills that could make them insider threats if they
were to get upset?

So those are the kinds of issues that we think need to be studied
in evaluating the national need here in comparison to other na-
tional needs.

Mr. Burgess. Thank you. Thank you, Dr. Kingsbury.

Mr. Chairman, I will yield back the balance of my time.

Mr. Stupak. Thank you. Let me just ask a question here. Mr.
Burgess and Mr. Gingrey brought up Plum Island. Both you and
Dr. Sharma did the report, the GAO report on moving the foot and
mouth disease off Plum Island to the mainland, right?

Ms. Kingsbury. That is correct.

Mr. Stupak. And if I remember correctly GAO did not conclude
that the DHS study showed that foot and mouth disease can be
done safely on the mainland?

Ms. Kingsbury. That is correct. I am not going to take a case.
Dr. Atlas’s belief that it could be done, but the evidence that we
were given in the environmental impact statements, and so forth,
do not demonstrate that point.

Mr. Stupak. Very good. Any other questions?

Mr. Burgess. Mr. Chairman, I would just ask unanimous con-
sent that my opening statement can be inserted in the record.

Mr. Stupak. We have done it earlier but fine. It will be entered.

I want to thank the witnesses for their testimony.

I want to be sure that GAO continues its oversight of the domes-
tic and international lab proliferation. Dr. Kingsbury, your team
has done good work, and I would ask that the GAO review the two
reports which will hopefully be out in the next few weeks. Around
here they always say a few weeks always means a few months, the
one being Trans-Federal Task Force for Optimizing Biosafety and
Biocontainment Oversight and the Executive Order Working Group
on Strengthening the Biosecurity of the United States. This sub-
committee would be interested in the proposals set forth in these
two reports. We are asking that GAO assess any recommendations
set forth in those reports and report back to us with your assess-
ment. Will you do that for us?

Ms. Kingsbury. Yes, sir.

Mr. Stupak. Thank you, and that concludes our hearing. Mem-
bers will have

Mr. Walden. Can I ask while we are together here just two
questions? One we had asked you and Chairman Waxman about
the opportunity to do an oversight hearing and invite up the auto
czar from the White House. We haven’t gotten a response to that
letter from the end of June.

Mr. Stupak. There have been a number of conversations going
back and forth. I think the 28th is the end of the program, and
speaking with some of the interest groups they said wait until we
get the program done and we will see what went wrong and what
went right with it. So there is still some interest in doing one. Yes.

Mr. Walden. And the other issue involves insurance. I know
that you and Mr. Waxman sent a letter to 52 heads of insurance
companies asking for their financial information. I am wondering
if we are any closer in knowing when we might have a hearing in-
volving that issue.

Mr. Stupak. We are kicking around some calendar dates. As you
know, the majority leader has just given us some dates back, if you
will, some Fridays, there has been some discussions if we are here
on Thursday can we do a Friday morning hearing to get some of
them done. We would like to have some hearings, not just on the

insurance industry but also what is the effect on small businesses
and the cost of health insurance. I look forward to spending the
next month and doing some hearings on insurance. I know we all
have an interest in that.

Mr. Walden. So within the next 30 days we may have multiple
hearings on these issues?

Mr. Stupak. We would like to assess how does the information
come in and where we are going with it.

Mr. Walden. Will we be looking at other contributors to that
cost equation other than just the executive comp on insurance com-
panies?

Mr. Stupak. What is the cost on small businesses, if you have
some examples, we would be happy to hear it. I just received one
yesterday, about 30 percent increase for a small business.

Mr. Walden. I was a small business owner for 22 years. I never
throw the dart high enough on the budget planning board.

Mr. Stupak. Is the 33 percent increase going into health care or
is it going into other objects? That is what we want to know.

Mr. Walden. Thank you very much.

Mr. Stupak. Thank you.

Mr. Burgess. Mr. Chairman, along that same line, if I could ask
you or the ranking member, has that information that was gath-
ered from those companies, has that been, has the majority staff
shared that with the minority staff?

Mr. Stupak. Everything we have, we haven’t even received ev-
erything from every request we have made but the information wee
received, minority class — staff — and they are class, has had access
to it, and then it will continue, continue to have access to it.

OK, committee will provide and members have 10 days to submit
additional questions for the record. So if there are any more ques-
tions we will get them to the appropriate party. That concludes our
hearing. The meeting of the subcommittee is adjourned.

[Whereupon, at 12:30 p.m., the subcommittee was adjourned.]

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